Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-27 @ 12:23 AM
Study NCT ID:
NCT01365403
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE CARBAMAZEPINE ON SINGLE DOSE PHARMACOKINETICS OF RO4917838 IN HEALTHY MALE VOLUNTEERS
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: