Interaction Study SLV337/Simvastatin
Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin
- Registration Number
- NCT00924430
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
- Volunteers with Body Mass Index 18.0-28.0 kg/m2
Exclusion Criteria
- Clinically relevant medical history
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin - 2 Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin -
- Primary Outcome Measures
Name Time Method Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only 20 days
- Secondary Outcome Measures
Name Time Method SLV337 and its acylglucuronide metabolite: Cmax, tmax, AUC0-24, AUC0-t, CL/F (SLV337 only) on Days 1 and 13, as well as AUC, lz, t1/2 and Vz/F (SLV337 only) on Day 1 20 days Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs During the duration of study participation
Trial Locations
- Locations (1)
Site 1
🇬🇧London, United Kingdom
Site 1🇬🇧London, United Kingdom