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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT01183585 |
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Date of registration:
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13/08/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of RO4917838 With Rosuvastatin in Healthy Volunteers
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Scientific title:
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A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of RO4917838 on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01183585 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteer
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Intervention(s)
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Drug: RO4917838 and Rosuvastatin
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Primary Outcome(s)
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To determine the effect of multiple doses of RO4917838 on single-dose pharmacokinetics of Rosuvastatin
[Time Frame: 30 days]
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Secondary Outcome(s)
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To explore the effect of single-dose Rosuvastatin on steady-state pharmacokinetics of RO4917838
[Time Frame: 30 days]
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To evaluate the safety and tolerability of single-dose Rosuvastatin and multiple-dose RO4917838 alone and in combination
[Time Frame: 30 days]
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Secondary ID(s)
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BP25262
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2010-020082-24
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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