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A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy Participants

NCT03649997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-04-27

No results posted yet for this study

Summary

The purpose of this 3 part study are; Part 1: to investigate the pharmacokinetic (PK), safety and tolerability of JNJ-61393215 suspension (ascending dose levels) after single oral dose administration under fasted conditions, Part 2: to evaluate the relative bioavailability of a solid JNJ-61393215 capsule formulation compared to a suspension of JNJ-61393215 under fasted conditions, and the effect of food on the PK of the solid JNJ-61393215 capsule formulation, Part 3: to investigate the PK, safety, and tolerability of JNJ-61393215 suspension (ascending dose levels) after 7 days of once daily dosing in under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

JNJ-61393215

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.

DRUG

Placebo

Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.

DRUG

JNJ-61393215

Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2018-12-14
Completion
2018-12-14

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649997 on ClinicalTrials.gov