A Study Evaluating Drug Drug Interaction Between Milvexian and Atorvastatin in Healthy Participants

NCT04388501 | Completed Phase 1

• 3 other identifiers: CR1087762019-004640-2970033093THR1002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the potential pharmacokinetics (PK) interaction between milvexian and atorvastatin (and its metabolites) in healthy participants at steady state.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax) of Milvexian at Steady State

  Cmax is the maximum observed plasma concentration of milvexian at Steady State.

  Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14 hours after drug administration on Day 5 in Period 1, 2, 3

• Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24hours]) of Milvexian at Steady State

  AUC(0-24 hours) is the area under the plasma concentration-time curve from time zero to 24 hours of milvexian at Steady State.

  Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14 hours after drug administration on Day 5 in Period 1, 2 and 3

• Maximum Observed Plasma Concentration (Cmax) of Atorvastatin at Steady State

  Cmax is the maximum observed plasma concentration of Atorvastatin at Steady State.

  Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14 hours after drug administration on Day 5 in Period 1, 2, 3

• Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24hours]) of Atorvastatin in Healthy Participants at Steady State

  AUC(0-24 hours) is the area under the plasma concentration-time curve from time zero to 24 hours of Atorvastatin at Steady State.

  Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14 hours after drug administration on Day 5 in Period 1, 2 and 3

Secondary Outcomes (6)

• Cmax of Milvexian After a Single Dose Administration

  Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24, 48, 72 hours after drug administration on Day 1 in Period 1, 2, 3

• AUC(0-24 hours) of Milvexian After a Single Dose Administration

  Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24 hours after drug administration on Day 1 in Period 1, 2, 3

• Cmax of Atorvastatin After a Single Dose Administration

  Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24, 48, 72 hours after drug administration on Day 1 in Period 1, 2, 3

• AUC(0-24 hours) of Atorvastatin After a Single Dose Administration

  Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24 hours after drug administration on Day 1 in Period 1, 2, 3

• Number of Participants with Adverse Event as a Measure of Safety and Tolerability

  Up to 3.4 months

Study Arms (6)

Treatment Sequence ABC

EXPERIMENTAL

Participants will receive milvexian capsule once daily (qd) for 5 days (Treatment A) in Period 1 followed by Atorvastatin tablets qd for 5 days (Treatment B) in Period 2 followed by milvexian capsules qd and atorvastatin tablets qd for 5 days (Treatment C) in Period 3. Each period is separated by a washout period of 7 days.

Drug: Milvexian; Drug: Atorvastatin

Treatment Sequence BCA

EXPERIMENTAL

Participants will receive Treatment B in Period 1 followed by Treatment C in Period 2 and Treatment A in Period 3. Each Period is separated by a washout period of 7 days.

Drug: Milvexian; Drug: Atorvastatin

Treatment Sequence CAB

EXPERIMENTAL

Participants will receive Treatment C in Period 1 followed by Treatment A in Period 2 and Treatment B in Period 3. Each Period is separated by a washout period of 7 days.

Drug: Milvexian; Drug: Atorvastatin

Treatment Sequence CBA

EXPERIMENTAL

Participants will receive Treatment C in Period 1 followed by Treatment B in Period 2 and Treatment A in Period 3. Each Period is separated by a washout period of 7 days.

Drug: Milvexian; Drug: Atorvastatin

Treatment Sequence ACB

EXPERIMENTAL

Participants will receive Treatment A in Period 1 followed by Treatment C in Period 2 and Treatment B in Period 3. Each Period is separated by a washout period of 7 days.

Drug: Milvexian; Drug: Atorvastatin

Treatment Sequence BAC

EXPERIMENTAL

Participants will receive Treatment B in Period 1 followed by Treatment A in Period 2 and Treatment C in Period 3. Each Period is separated by a washout period of 7 days.

Drug: Milvexian; Drug: Atorvastatin

Interventions

Milvexian DRUG

Participants will receive milvexian capsules orally qd for 5 days as per the assigned treatment sequence.

Also known as: BMS-986177, JNJ-70033093

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment Sequence CBA

Atorvastatin DRUG

Participants will receive atorvastatin tablets orally qd for 5 days as per the assigned treatment sequence.

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment Sequence CBA

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, Electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis, performed at screening.
• Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) of greater than or equal to (\>=) 90 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
• Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and are willing to participate in the study
• If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and urine (beta-hCG) pregnancy test on Day 1 of each treatment period
• Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

You may not qualify if:

• Participant is a woman who is pregnant, breastfeeding, or planning to become pregnant during this study or within 34 days after the last study drug administration
• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, gastrointestinal disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology, coagulation, clinical chemistry (including thyroid-stimulating hormone \[TSH\] at screening only), or urinalysis at screening or on Day 1 prior to the first dosing, including: Hemoglobin and hematocrit less than (\<) lower limit of normal; Platelet count \< lower limit of normal; and activated partial thromboplastin time (aPTT) or prothrombin time (PT) greater than (\>) 1.2\* upper limit of normal (ULN)
• Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening or at admission to the study center on Day 1 prior to first dosing, as deemed appropriate by the investigator
• Participants with a history of excessive menstrual bleeding

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

milvexian; Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  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: May 12, 2020
• First Posted: May 14, 2020
• Study Start: June 7, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 27, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)