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