A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382

Plain-language summary

This study investigated the safety, tolerability and blood levels (pharmacokinetics) of single oral doses of a drug called JNJ-47910382 in healthy volunteers. It enrolled healthy non-smoking participants aged 18 to 45. It was carried out in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Janssen R&D Ireland

Intervention

JNJ-47910382, JNJ-47910382, JNJ-47910382, JNJ-47910382, Placebo, Placebo, Placebo, Placebo

Start date

11/1/2011

Estimated completion

4/1/2012

Countries

Germany

Related genes

Locations

• Neuss, Germany

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Caucasian subjects between 18 and 45 years of age, inclusive.
* Japanese subjects between 20 and 45 years of age, inclusive.
* MALE Japanese subjects who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese
* A body weight above 50 kg at screening
* Non-smoking for at least 3 months prior to screening

Exclusion Criteria:

* Female Caucasian, except if postmenopausal for at least 2 years or be surgically sterile.
* Hepatitis A, B or C infection
* Human Immunodeficiency Virus Type 1 (HIV-1) or Human Immunodeficiency Virus Type 2 (HIV-2) infection