A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01183585
First received: August 13, 2010
Last updated: April 7, 2014
Last verified: April 2014

August 13, 2010
April 7, 2014
August 2010
September 2010   (final data collection date for primary outcome measure)
To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01183585 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of RO4917838 With Rosuvastatin in Healthy Volunteers
A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of RO4917838 on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer
Drug: RO4917838 and Rosuvastatin
multiple oral doses of RO4917838 and single oral dose of Rosuvastatin
Experimental: 1
Intervention: Drug: RO4917838 and Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01183585
BP25262, 2010-020082-24
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP