A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01367756
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease)
- Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
- Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug
- Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males)
- Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug
Exclusion Criteria
- Pregnant or lactating females
- Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2
- Hepatitis B, hepatitis C or HIV infection
- Smokers of >5 cigarettes or equivalent tobacco intake per day
- Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable)
- Participation in an investigational drug or device study within 3 months prior to dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo - 1 citalopram - 2 citalopram - 1 RO4995819 -
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events up to 58 days
- Secondary Outcome Measures
Name Time Method Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram 17 days Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram up to 58 days