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

A Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and an Open-Label Study to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants

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 Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: JNJ-61803534; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Merksem, Belgium, 2170
    • Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Single Ascending Dose (SAD); Participants will receive single oral doses of JNJ-61803534 or placebo in the fasted or fed state.	Drug: Placebo; Participants will receive matching placebo.; Drug: JNJ-61803534; Participants will receive JNJ-61803534 tablets orally.
Experimental: Part 2: Multiple Ascending Dose (MAD); Participants will receive JNJ-61803534 or placebo over a 14-day period.	Drug: Placebo; Participants will receive matching placebo.; Drug: JNJ-61803534; Participants will receive JNJ-61803534 tablets orally.
Experimental: 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.	Drug: JNJ-61803534; Participants will receive JNJ-61803534 tablets orally.; Drug: Midazolam; Participants will receive single oral dose of midazolam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): April 5, 2018
• Study Completion (Actual): April 5, 2018

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: CR108320; 2016-004085-26 (EudraCT Number); 61803534NAP1001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No