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A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Participants

NCT03180762 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-10-30

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (ascending dose levels) under fasted condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the PK of JNJ-64140284 following single oral dose administration.

Conditions

  • Healthy

Interventions

DRUG

JNJ-64140284 0.1 mg

0.1 mg of JNJ-64140284 will be administered as an oral solution.

DRUG

JNJ-64140284 0.5 mg

0.5 mg of JNJ-64140284 will be administered as an oral solution.

DRUG

JNJ-64140284 2.5 mg

2.5 mg of JNJ-64140284 will be administered as an oral solution.

DRUG

JNJ-64140284 10 mg

10 mg of JNJ-64140284 will be administered as an oral solution.

DRUG

JNJ-64140284 50 mg

50 mg of JNJ-64140284 will be administered as an oral solution.

DRUG

JNJ-64140284 150 mg

150 mg of JNJ-64140284 will be administered as an oral solution.

DRUG

JNJ-64140284 (dose to be determined [TBD])

JNJ-64140284 (dose to be determined) will be administered as an oral solution.

DRUG

Placebo

Matching placebo will be administered.

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
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2017-09-25
Completion
2017-09-25

Countries

  • Belgium

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 NCT03180762 on ClinicalTrials.gov