Status:
COMPLETED
A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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 enro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01409369
Start Date
August 1 2011
End Date
February 1 2012
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rennes, France, 35042