A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers
- Registration Number
- NCT01365403
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
- Adult healthy male volunteers, 18-65 years of age inclusive
- Body mass index (BMI) 18-30 kg/m2 inclusive
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm RO4917838 - Single Arm carbamazepine -
- Primary Outcome Measures
Name Time Method Area under the concentraion-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration approximately 4 weeks
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events up to 13 weeks