Healthy Volunteer
Conditions
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.
Interventions
DRUGRO4917838 and Rosuvastatin
multiple oral doses of RO4917838 and single oral dose of Rosuvastatin
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult healthy volunteers, 18 to 65 years of age * A body mass index (BMI) between 18 to 30 kg/m2
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed