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A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

NCT ID: NCT01636492

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-08-31

Brief Summary

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This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.

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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Bitopertin

Group Type EXPERIMENTAL

bitopertin

Intervention Type DRUG

Single oral dose

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Single oral dose

Interventions

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bitopertin

Single oral dose

Intervention Type DRUG

placebo

Single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male healthy volunteer, 18 to 60 years of age inclusive
* Body mass index (BMI) 19-35 kg/m2 inclusive
* Supine blood pressure within the normal range of the center and heart rate \>/= 40 provided QTcB is \<450 ms
* Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion

Exclusion Criteria

* History or evidence of any clinically significant disease or disorder
* Clinically significant ECG abnormalities
* Positive for hepatitis B, hepatitis C or HIV infection
* Previous treatment with iron for iron deficiency anemia
* Regular smoker (\>10 cigarettes, \>3 pipefuls or \>3 cigars per day)
* History of alcohol and/or drug abuse or addiction within the last 2 years before study start
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Participation in a clinical study with an investigational drug within the last three months prior to screening
* Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigators or their designee
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

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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Christchurch, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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BP19292

Identifier Type: -

Identifier Source: org_study_id