Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-29 @ 3:31 AM
Study NCT ID:
NCT01799603
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Single-dose, Open-label, Randomized, Two-way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of TMC435 in Japanese Healthy Adult Male Subjects
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.
Detailed Description:
This is an open-label (all people know the identity of the intervention), single-center, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical trial) and randomized (the study drug is assigned by chance) study to assess the effect of food on the pharmacokinetics of TMC435 after a single dose in Japanese healthy adult male participants. The study duration will be of 44 days per participant, which is divided into 3 parts: Screening (from Day -28 to Day -2); Treatment (consists of 2 treatment periods of 5 days each \[that is, Day -1 to 4, in-patient period\], wherein all participants will receive TMC435 in the respective period, and the period will be separated by washout period of 9 days); and Follow-up (on Day 7 of Period 2). Participants will keep upright position from the time of study drug administration until 4 hours after study drug administration. Participants will not be allowed to ingest meal until 4 hours post-dose. Participants will have standardized lunch and dinner at 4 hours and 10 hours post-dose, respectively. Drinking water will not be allowed from 1 hour before the administration up to 1 hour after administration except for the water served with the study drug and meal. Pharmacokinetics will be assessed in blood samples which will be collected up to 72 hours after administration of study drug. Participants' safety will be monitored throughout the study.
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 |
|---|---|---|---|---|
| TMC435HPC1007 | None | None | View |