A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of RO4917838 on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183585
• Other study ID #: BP25262
• Secondary ID: 2010-020082-24
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2010
• Last updated: November 1, 2016
• Start date: August 2010
• Est. completion date: September 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence francaise de securite sanitaire des produits de sante
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917838 and Rosuvastatin
multiple oral doses of RO4917838 and single oral dose of Rosuvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin		30 days	No
Secondary	To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination		30 days	No
Secondary	To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838		30 days	No