A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819
- Registration Number
- NCT01409369
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
Inclusion Criteria
- Healthy male subjects, 18 to 65 years of age, inclusive
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug
- Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances.
Exclusion Criteria
- Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
- Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2
- Participation in an investigational drug or device study within 3 months prior to first administration of the study drug
- Any confirmed allergic reaction against any drug or multiple allergies
- Dietary restrictions that would prohibit the consumption of standardized meals
- Positive cotinine test and/or any use of nicotine containing products
- Clinically relevant history of constipation or bowel disorder
- Known intolerability to activated charcoal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 RO4995819 - 1 RO4995819 - 1 activated charcoal -
- Primary Outcome Measures
Name Time Method C max: maximum observed plasma concentration 18 weeks T max: time of maximum observed plasma concentration 18 weeks T1/2: apparent terminal half-life 18 weeks AUC: area under the plasma concentration-time curve 18 weeks
- Secondary Outcome Measures
Name Time Method