Healthy Volunteer
Conditions
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.
Interventions
DRUGCarbamazepine
Multiple doses of carbamazepine
DRUGRO4917523
Single dose of RO4917523
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety: incidence of adverse events | 6 weeks |
Countries
France
Outcome results
None listed