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

Healthy Clinical Trial

Official title:

A Single-center, Open-label, Randomized, Three-way Cross-over Study Evaluating Drug Drug Interaction Between JNJ-70033093 and Atorvastatin in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388501
• Other study ID #: CR108776
• Secondary ID: 2019-004640-2970
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2021
• Est. completion date: October 27, 2021

Study information

• Verified date: December 2021
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 27, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Milvexian
Participants will receive milvexian capsules orally qd for 5 days as per the assigned treatment sequence.
• Atorvastatin
Participants will receive atorvastatin tablets orally qd for 5 days as per the assigned treatment sequence.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Cmax of Milvexian After a Single Dose Administration	Cmax is the maximum observed plasma concentration of milvexian after single dose administration on Day 1.	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
Secondary	AUC(0-24 hours) of Milvexian After a Single Dose Administration	AUC(0-24 hours) is the area under the plasma concentration-time curve from time zero to 24 hours of milvexian after single dose administration on Day 1.	Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24 hours after drug administration on Day 1 in Period 1, 2, 3
Secondary	Cmax of Atorvastatin After a Single Dose Administration	Cmax is the maximum observed plasma concentration of Atorvastatin after single dose administration on Day 1.	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
Secondary	AUC(0-24 hours) of Atorvastatin After a Single Dose Administration	AUC(0-24 hours) is the area under the plasma concentration-time curve from time zero to 24 hours of Atorvastatin after single dose administration on Day 1.	Predose, 0.5, 1, 2, 3, 4, 6, 10, 12, 14, 24 hours after drug administration on Day 1 in Period 1, 2, 3
Secondary	Number of Participants with Adverse Event as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 3.4 months
Secondary	Change From Baseline in Activated Partial Thromboplastin Time (aPTT)	Activated partial thromboplastin time measures the time to clot formation via the intrinsic (contact) and common pathways, and is dependent on activation of contact factors (such as FXI). The assay is triggered in citrated platelet-poor plasma by addition of phospholipids, a contact activator (typically a negatively charged substance, as kaolin or ellagic acid), and calcium. The time taken for a fibrin clot to form is measured in seconds.	Baseline, Day 2 and Day 6

External Links

•   To learn how to participate in this trial please click here.