A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants

NCT ID: NCT03139500

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2018-04-05

Brief Summary

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Single Ascending Dose (SAD)

Participants will receive single oral doses of JNJ-61803534 or placebo in the fasted or fed state.

Group Type: EXPERIMENTAL

JNJ-61803534

Intervention Type: DRUG

Participants will receive JNJ-61803534 tablets orally.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo.

Part 2: Multiple Ascending Dose (MAD)

Participants will receive JNJ-61803534 or placebo over a 14-day period.

Group Type: EXPERIMENTAL

JNJ-61803534

Intervention Type: DRUG

Participants will receive JNJ-61803534 tablets orally.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo.

Part 3: Drug-drug Interaction (DDI)

Participants will receive single oral doses of midazolam on Day 1 and Day 16 and will receive JNJ-61803534 daily from Day 3 through Day 16 for 14 days at a dose based on the data from the SAD and MAD part.

Group Type: EXPERIMENTAL

JNJ-61803534

Intervention Type: DRUG

Participants will receive JNJ-61803534 tablets orally.

Midazolam

Intervention Type: DRUG

Participants will receive single oral dose of midazolam.

Interventions

JNJ-61803534

Participants will receive JNJ-61803534 tablets orally.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo.

Intervention Type: DRUG

Midazolam

Participants will receive single oral dose of midazolam.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2), and a body weight of not less than 50 kilogram (kg)
• Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed during screening
• Participant must be healthy on the basis of clinical laboratory tests performed during screening and at Day -1
• A woman must have a negative urine pregnancy test at screening and a negative highly sensitive serum pregnancy test on Day -1

Exclusion Criteria

• Participant has a history of liver or renal insufficiency or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, dermatologic, rheumatologic, psychiatric, or metabolic disturbances
• Participant has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
• Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
• Participant has received an investigational treatment (including investigational vaccines) within 2 months or 5 half-lives (whichever is longer) or used an invasive investigational medical device within 3 months before the planned first dose of study treatment or is currently enrolled in an investigational study
• Participant had major surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study treatment administration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 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

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2016-004085-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

61803534NAP1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108320

Identifier Type: -

Identifier Source: org_study_id