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

Phase 1TerminatedNCT03139500

Janssen Research & Development, LLC47 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

JNJ-61803534DRUG

Participants will receive JNJ-61803534 tablets orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Approximately up to 12 weeks

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

Time frame: Approximately up to 14 weeks

Secondary Outcomes

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

Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of of JNJ-61803534.

Time frame: 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)

Plasma concentration assessment will be done to characterize the effect of JNJ-61803534 on the PK of midazolam.

Time frame: Pre-dose and up to Day 18

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

The amount of IL-17A secreted during the ex-vivo stimulation will be measured during the dosing period.

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