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A Double Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Subjects
The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618 administered for 7 consecutive days in healthy adult male participants.
Details
| Lead sponsor | Janssen Cilag N.V./S.A. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 84 |
| Start date | 2013-11 |
| Completion | 2014-05 |
Conditions
- Healthy Volunteers
Interventions
- JNJ-38877618: Part 1a
- JNJ-38877618: Part 1b
- JNJ-38877618: Part 1c (optional)
- JNJ-38877618: Part 2
- JNJ-38877618: Part 3
- JNJ-38877618: Part 4 (optional)
- Placebo: Parts 1a, 2, 3, and 4 (optional)
Primary outcomes
- Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT) — Up to 30 days after the last dose of study medication
- Time to reach the maximum observed plasma concentration of JNJ-38877618 — Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
- Area under the plasma concentration-time curve from time 0 to 24-hours post dose of JNJ-38877618 — Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
- Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration — Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
- Area under the plasma concentration-time curve from time 0 to infinite time of JNJ-38877618 — Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
- Elimination half-life of JNJ-38877618 — Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Countries
United Kingdom