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A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

NCT ID: NCT01367756

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

RO4995819

Intervention Type DRUG

multiple oral doses, Days 10-16

citalopram

Intervention Type DRUG

multiple oral doses, Days 1-16

2

Group Type PLACEBO_COMPARATOR

citalopram

Intervention Type DRUG

multiple oral doses, Days 1-16

placebo

Intervention Type DRUG

multiple oral doses, Days 10-16

Interventions

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RO4995819

multiple oral doses, Days 10-16

Intervention Type DRUG

citalopram

multiple oral doses, Days 1-16

Intervention Type DRUG

placebo

multiple oral doses, Days 10-16

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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BP25679

Identifier Type: -

Identifier Source: org_study_id