A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01367756

Enrollment

Registered

2011-06-07

Start date

2011-05-31

Completion date

2011-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGRO4995819

multiple oral doses, Days 10-16

DRUGcitalopram

multiple oral doses, Days 1-16

DRUGplacebo

multiple oral doses, Days 10-16

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	up to 58 days

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026