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A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: RO4995819 (Drug); citalopram (Drug); placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Safety: Incidence of adverse events

Secondary outcome:

Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram

Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


Locations and Contacts

Strasbourg 67064, France
Additional Information

Starting date: May 2011
Last updated: August 17, 2015

Page last updated: August 23, 2015

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