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A Study of RO6799477 in Healthy Volunteers

NCT ID: NCT01893437

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-10-31

Brief Summary

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This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.

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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Single oral dose group

Group Type EXPERIMENTAL

RO6799477

Intervention Type DRUG

Single doses of RO6799477

Interventions

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RO6799477

Single doses of RO6799477

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male healthy volunteers, aged 18-45 years, inclusive
* Male volunteers with female partner of childbearing potential must agree to use an effective form of birth control during the study and for 3 months after discontinuation of treatment.
* Body Mass index (BMI) of 18-30 kg/m2, inclusive

Exclusion Criteria

* Infection with human immunodeficiency virus antibody (HIV 1 and 2), Hepatitis B, hepatitis C
* Positive testing for drugs of abuse
* Any history of alcohol and/or drug of abuse addiction
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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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Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2013-000402-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28751

Identifier Type: -

Identifier Source: org_study_id