A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO4917838 and Rosuvastatin

• 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

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-13
• Study First Posted: 2010-08-17
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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

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

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