Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-28 @ 6:03 AM
Study NCT ID:
NCT01442532
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
2011-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Participants will be assigned to either Part 1 or Part 2 of this study. Part 1 will be a single-center, double-blind (participants and study personnel will not know the identity of the treatments), randomized (treatment will be assigned by chance), single- and multiple-dose study. There will be 3 groups in Part 1, and the dosing will be as follows: Group A will receive a single oral dose of 30 mg JNJ-38518168 (given as three 10-mg tablets of JNJ-38518168) or placebo (a treatment identical in appearance to JNJ-38518168 but not containing active drug) (Period 1), and multiple oral doses of 30 mg JNJ 38518168 (given as three 10-mg tablets of JNJ-38518168) or matching placebo once daily for 14 consecutive days (Period 2); Group B will receive a single oral dose of 10 mg JNJ-38518168 or placebo (Period 1), and multiple oral doses of 10 mg JNJ-38518168 or placebo once daily for 14 consecutive days (Period 2); and Group C will receive a single oral dose of 3 mg JNJ-38518168 or placebo (Period 1), and multiple oral doses of 3 mg JNJ-38518168 or placebo once daily for 14 consecutive days (Period 2). At least a 20-day washout period will separate the dose administration in Period 1 and the first dose administration of Period 2. The duration of Part 1 will be approximately 78 days. Part 2 of this study will be a single-center, open-label (participants and study personnel will know the identity of the treatments), non-randomized, multiple dose, drug-drug interaction study. Eligible participants will receive a single oral dose of 2.5 mg of midazolam as oral solution on Day 1, three 10-mg tablets of JNJ-38518168 (30 mg) once daily for 14 consecutive days (Day 2 through Day 15); and another single oral dose of 2.5 mg midazolam on Day 15. The duration of Part 2 of the study will be approximately 42 days. Following an interim safety and PK data analysis, one additional treatment group may be studied to evaluate the effect of JNJ-38518168 at a dose lower than 30 mg once daily on the PK of midazolam. During Parts 1 or 2, participants may be admitted to the clinical unit for periods of up to 7 and 18 days, and follow-up return visits to the clinic will also be required.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 38518168ARA1002 | OTHER | Janssen Research & Development, LLC | View |