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A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers

NCT ID: NCT01495104

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

2011-10-31

Study Completion Date

2012-01-31

Brief Summary

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This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

RO4917838

Intervention Type DRUG

Multiple doses

valproate

Intervention Type DRUG

Multiple doses

Interventions

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RO4917838

Multiple doses

Intervention Type DRUG

valproate

Multiple doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers, 18 to 65 years of age inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Healthy as determined by the investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs, and a 12-lead electrocardiogram (ECG)
* Non smoker or smoker of fewer than 10 cigarettes per day

Exclusion Criteria

* History of alcoholism, drug abuse or addiction within the last year prior to Day -1 of the study
* Alcohol consumption averaging more than 24 g of alcohol per day
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
* Any major illness within the 4 weeks prior to dosing or any acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of study Day -1
* Any confirmed allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Positive for hepatitis B, hepatitis C or HIV infection
* Involvement in other investigational studies of any type within 90 days of first study drug administration or within 5 times the elimination half-life of the tested drug, whichever is longer
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

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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Rueil-Malmaison, , France

Site Status

Countries

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France

Other Identifiers

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2011-002256-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP25258

Identifier Type: -

Identifier Source: org_study_id