Pharmacokinetic and Safety of GSK573719 and GW642444 Administered Individually and Concurrently, With Verapamilin in Healthy Subjects
This study has been completed.
Information provided by (Responsible Party):
First received: May 20, 2010
Last updated: August 23, 2012
Last verified: February 2012
The purpose of this study is to see if the Pharmacokinetics and the Safety Profile of GSK573719 and GSK573719/GW642444 are effected by concurrent dosing with the PGP inhibitor verapamil.
Pulmonary Disease, Chronic Obstructive
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Single-Centre, Randomised, Open-label Study to Evaluate the Effects of Steady-State Verapamil, a Moderate P-Glycoprotein and CYP3A4 Inhibitor, on the Pharmacokinetics of GSK573719 and GSK573719 in Combination With GW642444|
Resource links provided by NLM:
Drug Information available for: Verapamil hydrochloride Diltiazem hydrochloride Diltiazem Diltiazem malateU.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Pharmacokinetic parameters of plasma and urine [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- General safety and tolerability endpoints: adverse events, heart rate, systolic and diastolic blood pressure, 12- lead ECG (QTc(B), QTc(F)) and clinical laboratory safety tests. 24hr Holter monitoring [ Time Frame: From first dose on day 1 through to Follow Up visit ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
13 days dosing with GSK573719, once daily dosing from day 1 to 13, concurrent dosing with verapamil from day 9 to 13.
13 days dosing with GSK573719/GW573719, once daily dosing from day 1 to 13, concurrent dosing with verapamil from day 9 to 13.
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