A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

Hoffmann-La Roche18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

RO4917838 and RosuvastatinDRUG

multiple oral doses of RO4917838 and single oral dose of Rosuvastatin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Strasbourg, France

Outcomes

Primary Outcomes

To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin

Time frame: 30 days

Secondary Outcomes

To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination

Time frame: 30 days

To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838

Time frame: 30 days

Data from ClinicalTrials.gov

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