A Study to Assess the Safety of Repeated Doses of GSK189075 and WELLBUTRIN SR in Healthy Male Subjects
The purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR and active metabolic products in blood samples when doses of both drugs are taken by mouth. Doses are either taken alone or together. The results will help to determine if doses of GSK189075 and WELLBUTRIN SR can be safely taken together.
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Randomized, 6-sequence, 3-period Crossover Drug-drug Interaction Study to Evaluate the Pharmacokinetics of WELLBUTRIN SR (Bupropion) and GSK189075 When Co-administered or Administered Alone in Healthy Male Volunteers|
- Blood samples and urine samples [ Time Frame: on Day 14 ]
- adverse events, heart rate & blood pressure: each visit ecg: screening, days -1, 1, 4, 7, 13, 14, followup lab tests: screening, days -1, 4, 7, 13, 14, followup
- GSK189074 Cmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR.
- Bupropion and GSK189074 tmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR.
- Steady-state AUC(0-12), Cmax, and tmax of the bupropion metabolites (hydroxybupropion, threohydrobupropion and erythrohydrobupropion) when WELLBUTRIN SR is administered alone and with GSK189075.
- Steady-state AUC(0-12), Cmax, and tmax of GSK189075, and GSK279782 when GSK189075 is administered alone and with WELLBUTRIN SR.
- Safety and tolerability parameters, including adverse events (AEs), vital signs, ECGs and clinical laboratory assessments, including urine electrolytes (Na, Cl, K, Ca and Mg).
- Urine volume, urine glucose concentration, and urine creatinine concentration to determine fractional urine glucose excretion over a specified time interval (0-24h).
- Hunger and craving will be assessed using two assessment tools: (1) a questionnaire to assess hunger and craving; and (2) a Visual Analogue Scale (VAS) to assess hunger.
|Study Start Date:||January 2008|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625859
|United States, New York|
|GSK Investigational Site|
|Buffalo, New York, United States, 14202|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|