A Study of the Safety and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Male Participants and the Effect of JNJ-38518168 on the Blood Levels of Midazolam
Public ClinicalTrials.gov record NCT01442532. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Randomized, Single- and Multiple-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Healthy Adult Male Subjects and an Open-Label Drug-Drug Interaction Study to Evaluate the Effect of JNJ-38518168 on the Pharmacokinetics of Midazolam, a CYP3A4 Substrate
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of Part 1 of this study is to evaluate the safety, tolerability, and pharmacokinetics ("PK", how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo following single dose and 14 days of consecutive dosing in healthy Japanese and Caucasian adult male participants. Part 2 of this study will evaluate the effect of JNJ-38518168 on the pharmacokinetics of midazolam in healthy participants.
Study identification
- NCT ID
- NCT01442532
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 94 participants
Conditions and interventions
Conditions
Interventions
- JNJ-38518168 (30 mg) Drug
- JNJ-38518168 (10 mg) Drug
- JNJ-38518168 (3 mg) Drug
- Placebo Drug
- Midazolam and JNJ-38518168 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- Jun 30, 2012
- Completion
- Jun 30, 2012
- Last update posted
- Mar 3, 2013
2011 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Cypress | California | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01442532, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2013 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01442532 live on ClinicalTrials.gov.