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

NCT03139500 | Terminated Phase 1

• 3 other identifiers: CR1083202016-004085-2661803534NAP1001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1

  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.

  Approximately up to 12 weeks

• Percentage of Participants With AEs as a Measure of Safety: Part 2

  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.

  Approximately up to 14 weeks

Secondary Outcomes (3)

• Plasma Concentration of JNJ-61803534 (Parts 1, 2 and 3)

  Pre-dose, up to Day 50 (Part 1), up to Day 60 (Part 2), and up to Day 63 (Part 3)

• Plasma Concentration of Midazolam (Part 3)

  Pre-dose and up to Day 18

• Inhibition of Stimulated IL-17A Production in Diluted Whole Blood (Parts 1 and 2)

  Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD)

Study Arms (3)

Part 1: Single Ascending Dose (SAD)

EXPERIMENTAL

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

Drug: JNJ-61803534; Drug: Placebo

Part 2: Multiple Ascending Dose (MAD)

EXPERIMENTAL

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

Drug: JNJ-61803534; Drug: Placebo

Part 3: Drug-drug Interaction (DDI)

EXPERIMENTAL

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.

Drug: JNJ-61803534; Drug: Midazolam

Interventions

JNJ-61803534 DRUG

Participants will receive JNJ-61803534 tablets orally.

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD); Part 3: Drug-drug Interaction (DDI)

Placebo DRUG

Participants will receive matching placebo.

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Midazolam DRUG

Participants will receive single oral dose of midazolam.

Part 3: Drug-drug Interaction (DDI)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: May 17, 2017
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

BE (1)