A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO4995819

Drug: activated charcoal

Study type

Interventional

Funder types

Industry

Identifiers

NCT01409369

BP25485

2011-000916-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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