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A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

NCT ID: NCT01629368

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

2012-06-30

Study Completion Date

2012-09-30

Brief Summary

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This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.

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

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Dosing Period 1

Group Type EXPERIMENTAL

RO4917523

Intervention Type DRUG

Single dose of RO4917523

Dosing Period 2

Group Type EXPERIMENTAL

Carbamazepine

Intervention Type DRUG

Multiple doses of carbamazepine

RO4917523

Intervention Type DRUG

Single dose of RO4917523

Interventions

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Carbamazepine

Multiple doses of carbamazepine

Intervention Type DRUG

RO4917523

Single dose of RO4917523

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers, 18-65 years of age inclusive
* Non-smokers
* Body mass index (BMI) between 18 and 30 mg/m2 inclusive
* Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception

Exclusion Criteria

* Evidence of any active or chronic disease
* History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
* History or presence of clinically significant psychiatric condition
* Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study
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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Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2012-000771-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28256

Identifier Type: -

Identifier Source: org_study_id