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A Study to Evaluate Bioavailability, Food Effect, Safety and Tolerability of a Solid Dosage Formulation of JNJ-54861911 in Healthy Older Male Participants

NCT02260700 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-10-09

No results posted yet for this study

Summary

The purpose of this study is to determine pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and the relative-bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-54861911 solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy older male participants.

Conditions

  • Healthy

Interventions

DRUG

JNJ-54861911 (Treatment A)

Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment A (oral suspension formulation) under fasted conditions in one of the treatment periods.

DRUG

JNJ-54861911 (Treatment B)

Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment B (solid formulation) under fasted conditions in one of the treatment periods.

DRUG

JNJ-54861911 (Treatment C)

Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment C (solid formulation) under fed conditions in one of the treatment periods.

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
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Belgium

Study Locations

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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 NCT02260700 on ClinicalTrials.gov