A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO4917838 and Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01183585

2010-020082-24

BP25262

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

1

Experimental group

Treatment:

Drug: RO4917838 and Rosuvastatin