A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: placebo

Drug: citalopram

Drug: RO4995819

Study type

Interventional

Funder types

Industry

Identifiers

NCT01367756

BP25679

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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