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A Study of RO5267683 in Healthy Subjects

NCT ID: NCT01398241

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-06-30

Brief Summary

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This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.

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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Active

Group Type EXPERIMENTAL

RO5267683

Intervention Type DRUG

Multiple ascending doses

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Multiple ascending doses

Interventions

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RO5267683

Multiple ascending doses

Intervention Type DRUG

placebo

Multiple ascending doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects, 18 to 45 years of age,
* Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening
* Female subjects must be surgically sterile or post-menopausal
* Male subjects must use a barrier method of contraception for the duration of the study and for 90 days after the last dose

Exclusion Criteria

* History or evidence of any clinically significant disease or disorder
* Administration of an investigational drug or device within 3 months prior to dosing on Day 1
* Positive for hepatitis B, hepatitis C or HIV at screening
* Subjects on hormone replacement therapy who have not been receiving a stable dose for at least 2 months prior to start of dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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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2011-000600-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP25214

Identifier Type: -

Identifier Source: org_study_id