A Single-Center, Open-Label, Two-Period Crossover Study to Investigate the Effect of Multiple Doses of Activated Charcoal on the Pharmacokinetics of a Single Oral Dose of RO4995819 in Healthy Subjects.
Overview
- Phase
- Phase 1
- Intervention
- RO4995819
- Conditions
- Healthy Volunteer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 26
- Primary Endpoint
- C max: maximum observed plasma concentration
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
2
Intervention: RO4995819
1
Intervention: RO4995819
1
Intervention: activated charcoal
Outcomes
Primary Outcomes
C max: maximum observed plasma concentration
Time Frame: 18 weeks
T max: time of maximum observed plasma concentration
Time Frame: 18 weeks
T1/2: apparent terminal half-life
Time Frame: 18 weeks
AUC: area under the plasma concentration-time curve
Time Frame: 18 weeks