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

Hoffmann-La Roche0 sites32 target enrollmentMay 2011

ConditionsHealthy Volunteer

InterventionsRO4995819 citalopram placebo

DrugsRO4995819 citalopram placebo

Overview

Phase: Phase 1
Intervention: RO4995819
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 32
Primary Endpoint: Safety: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

September 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1

Intervention: RO4995819

1

Intervention: citalopram

2

Intervention: citalopram

2

Intervention: placebo

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: up to 58 days

Secondary Outcomes

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)