A Study of RO4917838 With Rosuvastatin in Healthy Volunteers
- Registration Number
- NCT01183585
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single centre, open-label study will investigate the effect of RO4917838 on the pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers. Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of Rosuvastatin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Adult healthy volunteers, 18 to 65 years of age
- A body mass index (BMI) between 18 to 30 kg/m2
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Exclusion Criteria
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis (Gilbert's Syndrome is allowed)
- Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 RO4917838 and Rosuvastatin -
- Primary Outcome Measures
Name Time Method To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin 30 days
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination 30 days To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838 30 days