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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Carbamazepine; Drug: RO4917523

• Registration Number: NCT01629368
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-27
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dosing Period 2	Carbamazepine	-
Dosing Period 2	RO4917523	-
Dosing Period 1	RO4917523	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area under the concentration time curve	Period 1: Pre-dose and up to Day 14, Period 2: Pre-dose and up to Day 29

Secondary Outcome Measures

Name	Time	Method
Safety: incidence of adverse events	6 weeks