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A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers

NCT ID: NCT01365403

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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This open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.

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

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

RO4917838

Intervention Type DRUG

Single oral dose, Day 1 of study period 1 and Day 16 of study period 2

carbamazepine

Intervention Type DRUG

multiple oral doses, Days 1-24 of study period 2

Interventions

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RO4917838

Single oral dose, Day 1 of study period 1 and Day 16 of study period 2

Intervention Type DRUG

carbamazepine

multiple oral doses, Days 1-24 of study period 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult healthy male volunteers, 18-65 years of age inclusive
* Body mass index (BMI) 18-30 kg/m2 inclusive

Exclusion Criteria

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic or psychiatric disease, or cancer
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Native Asians or subjects with Asian racial origin
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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Rennes, , France

Site Status

Countries

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France

Other Identifiers

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BP25263

Identifier Type: -

Identifier Source: org_study_id