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A Single-Center Study of RO5508887 in Healthy Volunteers

NCT ID: NCT01664143

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

Brief Summary

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This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.

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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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Multiple doses of placebo

RO5508887

Group Type EXPERIMENTAL

RO5508887

Intervention Type DRUG

Multiple doses of RO5508887

Interventions

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Placebo

Multiple doses of placebo

Intervention Type DRUG

RO5508887

Multiple doses of RO5508887

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult healthy volunteers, \>/=18 years of age
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Use of adequate contraception methods or surgically sterile

Exclusion Criteria

* Evidence of active or chronic disease
* Regular consumption of drugs of abuse
* Regular smoker (\>5 cigarettes per day)
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
* History of significant allergic reactions
* Abnormal blood pressure
* Clinical significant abnormalities (e.g., cardiovascular, laboratory values)
Minimum Eligible Age

18 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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United States France

Other Identifiers

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2012-000280-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP28102

Identifier Type: -

Identifier Source: org_study_id