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A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers

NCT01054014 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-09-04

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and without food.

Conditions

  • Health

Interventions

DRUG

JNJ-40346527/Placebo

Single oral dose of JNJ-40346527 (either 10, 50, 150, 300, 600, or 1000mg) or Placebo

DRUG

JNJ-40346527/Placebo

JNJ-40346527 once daily oral dose for 14 days (either 50, 150, 300, 500 or 750mg) or Placebo

DRUG

JNJ-40346527

JNJ-40346527 150mg one dose, either fasting (or with food), then after 7 days off treatment, JNJ-40346527 150mg either with food (or fasting)

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Completion
2011-01-31

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 NCT01054014 on ClinicalTrials.gov