A Study to Assess the Safety of Repeated Doses of GSK189075 and WELLBUTRIN SR in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00625859
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Subjects receiving treatment sequence 1 Placebo Eligible subjects will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 2 GSK189075 Eligible subjects will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 4 GSK189075 Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 5 Placebo Eligible subjects will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 6 GSK189075 Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 6 Bupropion Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 1 GSK189075 Eligible subjects will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 2 Placebo Eligible subjects will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 5 GSK189075 Eligible subjects will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 3 GSK189075 Eligible subjects will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 3 Placebo Eligible subjects will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 4 Placebo Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 6 Placebo Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 1 Bupropion Eligible subjects will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 2 Bupropion Eligible subjects will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 3 Bupropion Eligible subjects will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 4 Bupropion Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075 Subjects receiving treatment sequence 5 Bupropion Eligible subjects will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075
- Primary Outcome Measures
Name Time Method Blood samples and urine samples on Day 14
- Secondary Outcome Measures
Name Time Method GSK189074 Cmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR. Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours 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 Up to Week 12 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. Up to Week 12 Bupropion and GSK189074 tmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR. Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours 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. Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours Steady-state AUC(0-12), Cmax, and tmax of GSK189075, and GSK279782 when GSK189075 is administered alone and with WELLBUTRIN SR. Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours Safety and tolerability parameters, including adverse events (AEs), vital signs, ECGs and clinical laboratory assessments, including urine electrolytes (Na, Cl, K, Ca and Mg). Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours Urine volume, urine glucose concentration, and urine creatinine concentration to determine fractional urine glucose excretion over a specified time interval (0-24h). Up to Week 12
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Buffalo, New York, United States