A Study of JNJ-70033093 (BMS-986177) in Healthy Adult Participants

NCT ID: NCT04223349

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2020-04-08

Brief Summary

The purpose of this study is to characterize the pharmacokinetic (PK) of multiple twice-daily doses of JNJ-70033093 in healthy participants and to assess the effects of dosing time and food on the PK of single-dose of JNJ-70033093 in healthy participants.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Treatment A

Participants will receive JNJ-70033093 dose twice daily (BID) for 8 days followed by a placebo dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Placebo

Intervention Type: DRUG

Matching placebo in capsule will be administered orally.

Part 1: Treatment B

Participants will receive JNJ-70033093 dose BID for 8 days followed by a placebo dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Placebo

Intervention Type: DRUG

Matching placebo in capsule will be administered orally.

Part 1: Treatment C

Participants will receive JNJ-70033093 dose BID for 8 days followed by a JNJ-70033093 dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Placebo

Intervention Type: DRUG

Matching placebo in capsule will be administered orally.

Part 1: Treatment D

Participants will receive JNJ-70033093 dose BID for 8 days followed by a JNJ-70033093 dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Placebo

Intervention Type: DRUG

Matching placebo in capsule will be administered orally.

Part 2: Treatment Sequence EFG

Participants will receive Treatment E (JNJ-7003309 single dose in the morning in fasted condition) in treatment Period 1; followed by Treatment F (JNJ-7003309 single dose administered in the evening in fasted condition) in treatment Period 2; followed by Treatment G (JNJ-7003309 single dose administered in the evening in fasted condition) in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Part 2: Treatment Sequence FGE

Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Part 2: Treatment Sequence GEF

Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Part 2: Treatment Sequence EGF

Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Part 2: Treatment Sequence GFE

Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Part 2: Treatment Sequence FEG

Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

JNJ-70033093 capsules will be administered orally .

Interventions

JNJ-70033093

JNJ-70033093 capsules will be administered orally .

Intervention Type: DRUG

Placebo

Matching placebo in capsule will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis performed at screening. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
• 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 treatment period
• Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
• Body mass index (BMI; weight kilogram per meter square [kg/m^2]) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kilogram (kg)
• After being supine for 10 minutes, systolic blood pressure between 90 and 140 millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood pressure

Exclusion Criteria

• If a woman, pregnant, breast-feeding or planning to become pregnant during the study
• 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, neoplastic abnormalities, metabolic disturbances, or poor venous access
• 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 HIV-2 infection at study screening
• History of, or a reason to believe a participant has a history of, drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM V) criteria within the past 1 year, which in the investigator's opinion would compromise participant safety and/or compliance with the study procedures
• 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 high-fat breakfast menu to be provided in this study
• Clinically significant abnormal values for hematology, coagulation, clinical chemistry or urinalysis at Screening or on Day -1 prior to the first dosing as determined by the investigator or appropriate designee. Any of the following laboratory results outside of the ranges specified below at screening or Day -1 prior to first dosing, confirmed by repeat: Hemoglobin or hematocrit < lower limit of normal; Platelet count < lower limit of normal; activated partial thromboplastin time (aPTT), or prothrombin time (PT) greater than (>) 1.2 × upper limit of normal (ULN)
• Any of the following on 12-lead ECG and assessment of QT interval prior to study treatment administration, confirmed by repeat at screening and Day -1 of treatment period: Heart rate >100 beats per minute (bpm); PR >= 210 milli second (ms); QRS >=120 ms; QTcF >= 450 ms for male and >= 470 ms for female

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

PRA Health Sciences

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

70033093THR1004

Identifier Type: OTHER

Identifier Source: secondary_id

CR108728

Identifier Type: -

Identifier Source: org_study_id