A Study of RO4917838 With Rosuvastatin in Healthy Volunteers
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01183585
First received: August 13, 2010
Last updated: April 18, 2011
Last verified: April 2011
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Healthy Volunteer |
Drug: RO4917838 and Rosuvastatin |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Enrollment: | 18 |
Study Completion Date: | January 2011 |
Arms | Assigned Interventions |
---|---|
Experimental: 1 |
Drug: RO4917838 and Rosuvastatin
multiple oral doses of RO4917838 and single oral dose of Rosuvastatin
|
Eligibility
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | Disclosures Group, Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01183585 History of Changes |
Other Study ID Numbers: | BP25262, 2010-020082-24 |
Study First Received: | August 13, 2010 |
Last Updated: | April 18, 2011 |
Health Authority: | France: Afssaps - Agence francaise de securite sanitaire des produits de sante |
Additional relevant MeSH terms:
Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 17, 2012