A Study Investigating Blood Concentrations Of Rosuvastatin When Co-administered With GW856553 In Healthy Men
Phase 1
Completed
- Conditions
- AtherosclerosisCardiovascular Disease
- Registration Number
- NCT00549653
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is being conducted to provide initial safety and tolerability data as well as to provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered in healthy male adults
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 44
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PK blood draws at days 14 and 28 days 14 and 28
- Secondary Outcome Measures
Name Time Method The primary pharmacokinetic endpoints of interest are AUC(0-τ) and Cmax for rosuvastatin days 14, 15, 28 The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin days 14, 15, 28 Measurement of alanine aminotransferase (ALT) and maximum change from baseline in ALT in all subjects days -1, 13, 14, 16, 18, 20, 22, 24, 26, 28, follow up Clinical safety data from spontaneous adverse event reporting, 12-lead ECG recording, vital sign measurement, nursing/physician observation and safety laboratory examination. days -1, 13, 14, 16, 22, 26, 28, follow up Analysis of LPS induction of IL-1b, IL-6, IL-8 and TNFa, as well as additional biomarkers, as data permit. day 1, 14, 21, 28
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Dallas, Texas, United States