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NCT01442532 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
NCT01442532 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 94 participants.
The verdict
NCT01442532, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG JNJ-38518168 (30 mg)
- DRUG JNJ-38518168 (10 mg)
- DRUG JNJ-38518168 (3 mg)
- DRUG Midazolam and JNJ-38518168
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01442532
The ClinicalTrials.gov registry entry for NCT01442532 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01442532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01442532 about?
NCT01442532 is a clinical study titled "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". 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 c...
What is the current status of trial NCT01442532?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2011-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01442532?
The interventions under investigation include: Placebo (DRUG), JNJ-38518168 (30 mg) (DRUG), JNJ-38518168 (10 mg) (DRUG), JNJ-38518168 (3 mg) (DRUG), Midazolam and JNJ-38518168 (DRUG).
Who is sponsoring clinical trial NCT01442532?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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