Sarilumab Effect on the Pharmacokinetics of Simvastatin
Phase 1
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT02017639
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the pharmacokinetics of simvastatin in patients with rheumatoid arthritis
Secondary Objective:
To describe the safety and efficacy (exploratory) of sarilumab
- Detailed Description
The duration of the entire study per patient completing both Parts A and B is expected to be approximately 58 weeks (not including Screening).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sarilumab SAR153191 (REGN88) sarilumab SAR153191 (REGN88) Single dose of simvastatin before and after sarilumab administration Sarilumab SAR153191 (REGN88) simvastatin Single dose of simvastatin before and after sarilumab administration
- Primary Outcome Measures
Name Time Method Assessment of PK parameters - area under curve from zero time until the last measurable concentration (AUClast) and AUC for simvastatin Day 1 of Period 1 and Day 8 of Period 2
- Secondary Outcome Measures
Name Time Method Assessment of additional PK parameters for simvastatin Day 1 of Period 1 and Day 8 of Period 2 Assessment of additional PK parameters for simvastatin acid Day 1 of Period 1 and Day 8 of Period 2 Safety assessment of sarilumab up to 1 year ) From Day 1 of Period 1 up to a maximum of 1 year (week 58)
Trial Locations
- Locations (5)
Investigational Site Number 840001
🇺🇸Dallas, Texas, United States
Investigational Site Number 410002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 840003
🇺🇸Jackson, Tennessee, United States
Investigational Site Number 840002
🇺🇸Duncansville, Pennsylvania, United States
Investigational Site Number 498001
🇲🇩Chisinau, Moldova, Republic of