A Study of JNJ-70033093 (Milvexian) in Healthy Adult Participants

NCT04844424 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10899970033093THR1008
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative bioavailability and food effect of a single dose of milvexian administered as direct compression (DC) oral tablets and roller compacted (RC) oral tablets compared with milvexian administered as Phase 2 oral capsules (Part 1) and of new concept tablets consisting of a single dose of milvexian administered as oral Tablet 1 and Tablet 2 compared with milvexian administered as Phase 2 oral capsules (Part 3) in healthy participants under fasting and fed conditions; to characterize the pharmacokinetics (PK) of multiple twice daily (BID) doses for 5 days of milvexian administered as DC oral tablets and Phase 2 oral capsules in healthy participants (Part 2) and to assess the effects of dosing time and food timing on the PK of single-dose of milvexian Phase 3 oral tablet formulation in healthy participants (Part 4) and to evaluate the relative bioavailability of a single dose of milvexian administered as oral film-coated DC whole tablets, oral film-coated DC tablets dispersed in water and then mixed with apple sauce, and oral film-coated DC tablets dispersed in water and administered as a suspension using a nasogastric (NG) tube in healthy participants under fasting conditions (Part 5).

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Area Under the Plasma Concentration-time Curve of Milvexian from Time Zero to Infinity (AUC [0-Infinity])

  AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.

  Up to 16 months

• Part 2: Area under the Plasma Concentration-time Curve of Milvexian From Time Zero to Time of Last Quantifiable Concentration (AUC [0-Last])

  AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration.

  Up to 16 months

• Maximum Observed Analyte Concentration (Cmax) of Milvexian

  Cmax is defined as maximum observed analyte concentration of milvexian.

  Up to 16 months

• Parts 1 and 3: AUC (0-Infinity) of Milvexian (Food effect)

  AUC (0-infinity) is defined as area under the plasma concentration-time curve of milvexian from time zero to infinity after administration.

  Up to 16 months

• Parts 1 and 3: AUC (0-Last) of Milvexian (Food effect)

  AUC (0-last) is defined as area under the plasma concentration-time curve of milvexian from time zero to time of last quantifiable concentration after administration.

  Up to 16 months

• Parts 1 and 3: Cmax of Milvexian (Food effect)

  Cmax is defined as maximum observed analyte concentration of milvexian.

  Up to 16 months

• Actual Sampling Time to Reach the Maximum Observed Analyte Concentration (Tmax) of Milvexian

  Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.

  Up to 16 months

• Parts 1 and 3: Tmax of Milvexian (Food effect)

  Tmax is defined as the actual sampling time to reach the maximum observed analyte concentration of milvexian.

  Up to 16 months

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to 16 months

Study Arms (44)

Part 1A: Treatment Sequence ABC

EXPERIMENTAL

Participants will receive a single oral Dose 1 of milvexian as direct compression (DC) tablets under fasting conditions (Treatment A) in Treatment Period 1, followed by a single oral Dose 1 of milvexian as roller compacted (RC) tablets under fasting conditions (Treatment B) in Treatment Period 2 and then a single oral Dose 1 of milvexian Phase 2 oral capsules under fasting conditions (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1A: Treatment Sequence BCA

EXPERIMENTAL

Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1A: Treatment Sequence CAB

EXPERIMENTAL

Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1A: Treatment Sequence ACB

EXPERIMENTAL

Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1A: Treatment Sequence BAC

EXPERIMENTAL

Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment C in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1A: Treatment Sequence CBA

EXPERIMENTAL

Participants will receive Treatment C in Treatment Period 1 followed by Treatment B in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period during Part 1A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1B: Treatment Sequence DEF

EXPERIMENTAL

Participants will receive a single oral Dose 1 of milvexian as DC oral tablets under fed conditions (Treatment D) in Treatment Period 1, followed by a single oral Dose 1 of milvexian as RC oral tablets under fed conditions (Treatment E) in Treatment Period 2 and then a single oral Dose 1 of milvexian as Phase 2 oral capsules under fed conditions (Treatment F) in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1B: Treatment Sequence EFD

EXPERIMENTAL

Participants will receive Treatment E in Treatment Period 1, followed by Treatment F in Treatment Period 2 and then Treatment D in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1B: Treatment Sequence FDE

EXPERIMENTAL

Participants will receive Treatment F in Treatment Period 1, followed by Treatment D in Treatment Period 2 and then Treatment E in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1B: Treatment Sequence DFE

EXPERIMENTAL

Participants will receive Treatment D in Treatment Period 1, followed by Treatment F in Treatment Period 2 and then Treatment E in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1B: Treatment Sequence EDF

EXPERIMENTAL

Participants will receive Treatment E in Treatment Period 1, followed by Treatment D in Treatment Period 2 and then Treatment F in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 1B: Treatment Sequence FED

EXPERIMENTAL

Participants will receive Treatment F in Treatment Period 1, followed by Treatment E in Treatment Period 2 and then Treatment D in Treatment Period 3 on Day 1 of each Treatment Period during Part 1B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 2A: Treatment Sequence GH

EXPERIMENTAL

Participants will receive twice daily (BID) oral Dose 1 of milvexian DC oral tablets (Treatment G) in Treatment Period 1, followed by BID oral Dose 1 of milvexian Phase 2 oral capsule (Treatment H) in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2A. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2.

Drug: Milvexian

Part 2A: Treatment Sequence HG

EXPERIMENTAL

Participants will receive Treatment H in Treatment Period 1, followed by Treatment G in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2A. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2.

Drug: Milvexian

Part 2B: Treatment Sequence IJ

EXPERIMENTAL

Participants will receive BID oral Dose 2 of milvexian DC oral tablet (Treatment I) in Treatment Period 1, followed by BID oral Dose 2 of milvexian Phase 2 oral capsule (Treatment J) in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2B. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2.

Drug: Milvexian

Part 2B: Treatment Sequence JI

EXPERIMENTAL

Participants will receive Treatment J in Treatment Period 1, followed by Treatment I in Treatment Period 2 up to Day 5 in each Treatment Period during Part 2B. There will be a wash-out period of more than 5 days between the evening dose of Day 5 of Treatment Period 1 and the morning dose of Day 1 of Treatment Period 2.

Drug: Milvexian

Part 3A: Treatment Sequence KLM

EXPERIMENTAL

Participants will receive single oral Dose 1 of milvexian as oral Tablet 1 under fasting conditions (Treatment K) in Treatment Period 1, followed by single oral Dose 1 of milvexian oral Tablet 2 under fasting conditions (Treatment L) in Treatment Period 2 and then single oral Dose 1 of milvexian as Phase 2 oral capsules under fasting conditions (Treatment M) in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3A: Treatment Sequence LMK

EXPERIMENTAL

Participants will receive Treatment L in Treatment Period 1, followed by Treatment M in Treatment Period 2 and then Treatment K in Treatment Period 3 on Day 1 of each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3A: Treatment Sequence MKL

EXPERIMENTAL

Participants will receive Treatment M in Treatment Period 1, followed by Treatment K in Treatment Period 2 and then Treatment L in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3A: Treatment Sequence KML

EXPERIMENTAL

Participants will receive Treatment K in Treatment Period 1, followed by Treatment M in Treatment Period 2 and then Treatment L in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3A: Treatment Sequence LKM

EXPERIMENTAL

Participants will receive Treatment L in Treatment Period 1, followed by Treatment K in Treatment Period 2 and then Treatment M in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3A: Treatment Sequence MLK

EXPERIMENTAL

Participants will receive Treatment M in Treatment Period 1, followed by Treatment L in Treatment Period 2 and then Treatment K in Treatment Period 3 on Day 1 in each Treatment Period during Part 3A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3B: Treatment Sequence NOP

EXPERIMENTAL

Participants will receive single oral Dose 1 of milvexian oral Tablet 1 under fed conditions (Treatment N) in Treatment Period 1, followed by single oral Dose 1 of milvexian oral Tablet 2 under fed conditions (Treatment O) in Treatment Period 2 and then single oral Dose 1 of milvexian Phase 2 oral capsule under fed conditions (Treatment P) in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3B: Treatment Sequence OPN

EXPERIMENTAL

Participants will receive Treatment O in Treatment Period 1, followed by Treatment P in Treatment Period 2 and then Treatment N in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3B: Treatment Sequence PNO

EXPERIMENTAL

Participants will receive Treatment P in Treatment Period 1, followed by Treatment N in Treatment Period 2 and then Treatment O in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3B: Treatment Sequence NPO

EXPERIMENTAL

Participants will receive Treatment N in Treatment Period 1, followed by Treatment P in Treatment Period 2 and then Treatment O in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3B: Treatment Sequence ONP

EXPERIMENTAL

Participants will receive Treatment O in Treatment Period 1, followed by Treatment N in Treatment Period 2 and then Treatment P in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 3B: Treatment Sequence PON

EXPERIMENTAL

Participants will receive Treatment P in Treatment Period 1, followed by Treatment O in Treatment Period 2 and then Treatment N in Treatment Period 3 on Day 1 in each Treatment Period during Part 3B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 4 A: Treatment Sequence QRS

EXPERIMENTAL

Participants will receive single oral Dose 1 of milvexian as Phase 3 oral tablets under fasting conditions (Treatment Q) in Treatment Period 1, followed by single oral Dose 1 of milvexian as Phase 3 oral tablets under fed conditions (Treatment R) in Treatment Period 2 and then single oral Dose 1 of milvexian as Phase 3 oral tablets under fed conditions (Treatment S) in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 4A: Treatment Sequence RSQ

EXPERIMENTAL

Participants will receive Treatment R in Treatment Period 1, followed by Treatment S in Treatment Period 2 and then Treatment Q in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 4A: Treatment Sequence SQR

EXPERIMENTAL

Participants will receive Treatment S in Treatment Period 1, followed by Treatment Q in Treatment Period 2 and then Treatment R in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 4A: Treatment Sequence QSR

EXPERIMENTAL

Participants will receive Treatment Q in Treatment Period 1, followed by Treatment S in Treatment Period 2 and then Treatment R in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 4A: Treatment Sequence RQS

EXPERIMENTAL

Participants will receive Treatment R in Treatment Period 1, followed by Treatment Q in Treatment Period 2 and then Treatment S in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 4A: Treatment Sequence SRQ

EXPERIMENTAL

Participants will receive Treatment S in Treatment Period 1, followed by Treatment R in Treatment Period 2 and then Treatment Q in Treatment Period 3 on Day 1 of each Treatment Period during Part 4A. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 4B: Treatment Sequence TU

EXPERIMENTAL

Participants will receive single oral Dose 1 of milvexian as Phase 3 oral tablet under fed conditions (Treatment T) in Treatment Period 1, followed by single oral Dose 2 of milvexian as Phase 3 oral tablet under fed conditions (Treatment U) in Treatment Period 2 on Day 1 of each Treatment Period during Part 4B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 4B: Treatment Sequence UT

EXPERIMENTAL

Participants will receive Treatment U in Treatment Period 1, followed by Treatment T in Treatment Period 2 on Day 1 of each Treatment Period during Part 4B. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Subpart 4A: Treatment Sequence VW

EXPERIMENTAL

All participants of Subpart 4A will undertake a mandatory taste assessment on Day 5 of period 3 or Day 15 before the discharge and will receive milvexian tablet dispersed in water without a sweetener orally via syringe (Treatment V) in Treatment Period 1, followed by milvexian tablet dispersed in water with sucralose sweetener orally via syringe (Treatment W) in Treatment Period 2. Participants will cleanse their palates using 2 rinse of mineral water and one unsalted cracker and wait for a time interval of at least 1-2 hours from start of dosing before the next taste round.

Drug: Milvexian

Subpart 4A: Treatment Sequence WV

EXPERIMENTAL

All participants of Subpart 4A will undertake a mandatory taste assessment on Day 5 of period 3 or Day 15 before the discharge and will receive Treatment W in Treatment Period 1, followed by Treatment V in Treatment Period 2. Participants will cleanse their palates using 2 rinse of mineral water and one unsalted cracker and wait for a time interval of at least 1-2 hours from start of dosing before the next taste round.

Drug: Milvexian

Part 5: Treatment Sequence XYZ

EXPERIMENTAL

Participants will receive a single oral Dose 1 of milvexian as DC whole tablets under fasting conditions (Treatment X) in Treatment Period 1 followed by a single oral Dose 1 of milvexian as DC tablets dispersed in water and then mixed with apple sauce under fasting conditions (Treatment Y) in Treatment Period 2 and then a single oral Dose 1 of milvexian as DC tablets dispersed in water administered through a nasogastric (NG) tube under fasting conditions (Treatment Z) in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 5: Treatment Sequence YZX

EXPERIMENTAL

Participants will receive Treatment Y in Treatment Period 1 followed by Treatment Z in Treatment Period 2 and then Treatment X in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 5: Treatment Sequence ZXY

EXPERIMENTAL

Participants will receive Treatment Z in Treatment Period 1 followed by Treatment X in Treatment Period 2 and then Treatment Y in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 5: Treatment Sequence XZY

EXPERIMENTAL

Participants will receive Treatment X in Treatment Period 1 followed by Treatment Z in Treatment Period 2 and then Treatment Y in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 5: Treatment Sequence YXZ

EXPERIMENTAL

Participants will receive Treatment Y in Treatment Period 1 followed by Treatment X in Treatment Period 2 and then Treatment Z in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Part 5: Treatment Sequence ZYX

EXPERIMENTAL

Participants will receive Treatment Z in Treatment Period 1 followed by Treatment Y in Treatment Period 2 and then Treatment X in Treatment Period 3 on Day 1 of each Treatment Period during Part 5. There will be a wash-out period of 5 days between Day 1 of adjacent treatment periods.

Drug: Milvexian

Interventions

Milvexian DRUG

Milvexian will be administered orally or via nasogastric route as tablets or capsules.

Also known as: JNJ-70033093, BMS-986177

Part 1A: Treatment Sequence ABC; Part 1A: Treatment Sequence ACB; Part 1A: Treatment Sequence BAC; Part 1A: Treatment Sequence BCA; Part 1A: Treatment Sequence CAB; Part 1A: Treatment Sequence CBA; Part 1B: Treatment Sequence DEF; Part 1B: Treatment Sequence DFE; Part 1B: Treatment Sequence EDF; Part 1B: Treatment Sequence EFD; Part 1B: Treatment Sequence FDE; Part 1B: Treatment Sequence FED; Part 2A: Treatment Sequence GH; Part 2A: Treatment Sequence HG; Part 2B: Treatment Sequence IJ; Part 2B: Treatment Sequence JI; Part 3A: Treatment Sequence KLM; Part 3A: Treatment Sequence KML; Part 3A: Treatment Sequence LKM; Part 3A: Treatment Sequence LMK; Part 3A: Treatment Sequence MKL; Part 3A: Treatment Sequence MLK; Part 3B: Treatment Sequence NOP; Part 3B: Treatment Sequence NPO; Part 3B: Treatment Sequence ONP; Part 3B: Treatment Sequence OPN; Part 3B: Treatment Sequence PNO; Part 3B: Treatment Sequence PON; Part 4 A: Treatment Sequence QRS; Part 4A: Treatment Sequence QSR; Part 4A: Treatment Sequence RQS; Part 4A: Treatment Sequence RSQ; Part 4A: Treatment Sequence SQR; Part 4A: Treatment Sequence SRQ; Part 4B: Treatment Sequence TU; Part 4B: Treatment Sequence UT; Part 5: Treatment Sequence XYZ; Part 5: Treatment Sequence XZY; Part 5: Treatment Sequence YXZ; Part 5: Treatment Sequence YZX; Part 5: Treatment Sequence ZXY; Part 5: Treatment Sequence ZYX; Subpart 4A: Treatment Sequence VW; Subpart 4A: Treatment Sequence WV

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment Period 1. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant, in which case the participant may be included
• Body mass index (BMI equals to \[=\] weight/height\^2) between 18 and 30 kilograms per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kg at screening

You may not qualify if:

• A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and urine pregnancy test on Day 1 of Treatment Period 1
• Before randomization, a woman must be either: a) Not of childbearing potential defined as: postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level greater than (\>) 40 international units per liter IU/L or milli-international units per milliliter (mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal replacement therapy (HRT), however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; b) Of childbearing potential and; practicing a highly effective method of contraception (failure rate of less than \[\<\] 1 percent \[%\] per year when used consistently and correctly) for at least 3 months prior to the study entry and; agrees to remain on a highly effective method of contraception throughout the study and for at least 34 days after the last dose of study drug
• During the study, a man who is sexually active with a woman of childbearing potential or with a woman who is pregnant must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/ film/cream/suppository)
• History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol-specified assessments. This may include but is not limited to any known bleeding or clotting disorder, a history of arterial or venous thrombosis, liver or renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplasm, metabolic disturbances, or poor venous access
• Clinically significant abnormal values for hematology, coagulation, clinical chemistry, or urinalysis at screening or on Day -1 of Treatment Period 1 as determined by the investigator or appropriate designee. Any of the following laboratory results outside of the normal ranges specified below at screening or Day -1 of Treatment Period 1 which must be confirmed by repeat: Hemoglobin or hematocrit less than (\<) lower limit of normal; Platelet count \< lower limit of normal; activated partial thromboplastin time (aPTT) or prothrombin time (PT) \>1.2\*upper limit of normal (ULN)
• Use of any agent, including but not limited to non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other anti-platelet agents, anticoagulants, fish oil capsules, ginkgo or any agent that can potentially increase the risk of bleeding within 14 days prior to the first dose of study drug administration
• History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation
• History of allergy to or unwillingness to consume any component of the standardized high-fat breakfast menu to be provided in this study
• Woman with history of excessive menstrual bleeding as determined by the investigator or appropriate designee
• Does not tolerate venipuncture

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

milvexian

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 14, 2021
• Study Start: April 14, 2021
• Primary Completion: May 6, 2022
• Study Completion: July 12, 2022
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)