A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers
Overview
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.
Full Title of Study: “A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration in Healthy Volunteers”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: September 2011
Interventions
- Drug: RO4995819
- multiple oral doses, Days 10-16
- Drug: citalopram
- multiple oral doses, Days 1-16
- Drug: placebo
- multiple oral doses, Days 10-16
Arms, Groups and Cohorts
- Experimental: 1
- Placebo Comparator: 2
Clinical Trial Outcome Measures
Primary Measures
- Safety: Incidence of adverse events
- Time Frame: up to 58 days
Secondary Measures
- Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram
- Time Frame: 17 days
- Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram
- Time Frame: up to 58 days
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Hoffmann-La Roche
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Clinical Trials, Study Director, Hoffmann-La Roche
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