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A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183585
First Posted: August 17, 2010
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
August 13, 2010
August 17, 2010
November 2, 2016
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 ]
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 ]
  • To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838 [ Time Frame: 30 days ]
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01183585
BP25262
2010-020082-24
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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