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A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants

NCT02398591 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-07-11

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of three dosages (250, 500, and 1000 milligram \[mg\], or maximum tolerated dose \[MTD\]) of JNJ 53718678 when administered as single dose in fasting conditions in healthy Japanese adult participants in 3 cohorts.

Conditions

  • Healthy

Interventions

DRUG

JNJ 53718678

JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.

DRUG

Placebo

Placebo matching to JNJ 53718678 will be orally administered once on Day 1.

Sponsors & Collaborators

  • Janssen Sciences Ireland UC

    lead INDUSTRY

Principal Investigators

  • Janssen Sciences Ireland UC Clinical Trials · Janssen Sciences Ireland UC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2015-07-15
Completion
2015-07-15

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT02398591 on ClinicalTrials.gov