An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.
This study has been completed.
Information provided by:
First received: January 17, 2007
Last updated: May 15, 2009
Last verified: May 2009
This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2. [ Time Frame: on Day 1 of Session 1 and on Days 1 and 14 of Session 2. ]
Secondary Outcome Measures:
- 12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2 [ Time Frame: day 1 session 1; days 1 & 14 session 2 ]
- vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2 [ Time Frame: day 1 session 1; days 1, 7 & 14 session 2 ]
|Study Start Date:||December 2006|
Contacts and Locations