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A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

NCT ID: NCT01183585

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RO4917838 and Rosuvastatin

Intervention Type DRUG

multiple oral doses of RO4917838 and single oral dose of Rosuvastatin

Interventions

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RO4917838 and Rosuvastatin

multiple oral doses of RO4917838 and single oral dose of Rosuvastatin

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2010-020082-24

Identifier Type: -

Identifier Source: secondary_id

BP25262

Identifier Type: -

Identifier Source: org_study_id