A Study of JNJ-70033093 in Healthy Participants

NCT04448964 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1088032020-000565-1770033093THR1005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a single dose of JNJ-70033093 SDD tablets in Part 1.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-70033093

  Cmax is defined as maximum observed plasma concentration after administration of JNJ-70033093.

  Up to 72 hours post dose

• Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of JNJ-70033093

  AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration after administration of JNJ-70033093.

  Up to 72 hours post dose

• Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of JNJ-70033093

  AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity after administration of JNJ-70033093.

  Up to 72 hours post dose

• Part 1 and 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-70033093

  Tmax is defined time to reach the maximum observed plasma concentration.

  Up to 72 hours post dose

• Part 1 and 2: Apparent Elimination Half-life (t1/2) of JNJ-70033093

  Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve.

  Up to 72 hours post dose

Secondary Outcomes (4)

• Part 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to 2 Months

• Part 1 and 2: Number of Participants with Clinically Significant Changes in Vital Signs

  Up to 2 Months

• Part 1 and 2: Number of Participants with Abnormalities in Electrocardiogram (ECG)

  Up to 2 Months

• Part 1 and 2: Number of Participants with Clinically Significant Changes in Physical Examination

  Up to 2 Months

Study Arms (8)

Part 1: Treatment Sequence ABC

EXPERIMENTAL

Participants will receive a single dose of JNJ-70033093 spray-dried dispersion (SDD) tablet under fasted conditions (Treatment A) in Treatment Period 1, followed by JNJ-70033093 SDD tablet in fed conditions (Treatment B) in Treatment Period 2, and then JNJ-70033093 SDD granule capsule under fasted conditions (Treatment C) in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Drug: JNJ-70033093

Part 1: 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 Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Drug: JNJ-70033093

Part 1: 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 Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Drug: JNJ-70033093

Part 1: 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 Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Drug: JNJ-70033093

Part 1: 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 Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Drug: JNJ-70033093

Part 1: 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 Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Drug: JNJ-70033093

Part 2: Treatment Sequence DE

EXPERIMENTAL

Participants will receive Treatment D (single dose of JNJ-70033093 SDD tablet in fed conditions) in Treatment Period 1, and then Treatment E (single dose of JNJ-70033093 SDD granule capsule under fasted conditions) in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Drug: JNJ-70033093

Part 2: Treatment Sequence ED

EXPERIMENTAL

Participants will receive Treatment E in Treatment Period 1, and then Treatment D in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Drug: JNJ-70033093

Interventions

JNJ-70033093 DRUG

JNJ-70033093 will be administered orally as per assigned treatment sequence.

Also known as: BMS-986177

Part 1: Treatment Sequence ABC; Part 1: Treatment Sequence ACB; Part 1: Treatment Sequence BAC; Part 1: Treatment Sequence BCA; Part 1: Treatment Sequence CAB; Part 1: Treatment Sequence CBA; Part 2: Treatment Sequence DE; Part 2: Treatment Sequence ED

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
• Healthy on the basis of safety laboratory tests performed at screening and on Day -1 of Period 1. If the results of the safety laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant
• 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 each treatment period
• Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and body weight not less than 50 kg at screening
• After being supine for 5 minutes, systolic blood pressure between 90 and 140 millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood pressure at screening and on Day -1 of Treatment Period 1
• Must sign an ICF indicating that they understand the purpose of, and procedures required for the study and is willing to participate in the study
• Before randomization, a woman must be either: a.) Not of childbearing potential (Postmenopausal- no menses for 12 months without an alternative medical cause and Permanently sterile- include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy); b.) of childbearing potential and practicing a highly effective method of contraception 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

You may not qualify if:

• 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.
• 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
• Use of any systemic strong cytochrome P450 P glycoprotein (\[CYP\] 3A4/P-gp) inducers (example, \[rifampin\]) or inhibitors (example, \[itraconazole\]) within 4 weeks before the first dose of the study drug
• Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen \[HBsAg\]), or hepatitis C infection (confirmed by hepatitis C virus \[HCV\] antibody), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) infection at study screening
• 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
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for hormonal contraceptives, hormone replacement therapy and paracetamol (acetaminophen) within 14 days before the first dose of the study drug until completion of the study
• Any of the following on a 12-lead electrocardiogram (ECG) and the assessment of QT interval, confirmed by repeat at screening and Day -1 of Treatment Period 1: a.) Heart rate greater than (\>) 100 beats per minute (bpm); b.) PR \> 210 milliseconds (ms); c.) QRS \> 120 ms; d.) QT corrected according to Fridericia's formula (QTcF) \> 450 ms for male and \> 470 ms for female

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

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: June 25, 2020
• First Posted: June 26, 2020
• Study Start: June 26, 2020
• Primary Completion: November 14, 2020
• Study Completion: November 14, 2020
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)