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A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers

NCT ID: NCT01461967

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

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1a

Group Type EXPERIMENTAL

RO5508887

Intervention Type DRUG

Single ascending doses

Part 1b

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single ascending doses

Part 2

Group Type EXPERIMENTAL

RO5508887

Intervention Type DRUG

Single doses

Interventions

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Placebo

Single ascending doses

Intervention Type DRUG

RO5508887

Single ascending doses

Intervention Type DRUG

RO5508887

Single doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease
* Body Mass Index (BMI) 18 to 30 kg/m2 inclusive
* Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose

Exclusion Criteria

* Suspicion of regular consumption of drugs of abuse
* Regular smoker (\>5 cigarettes, \>1 pipeful or \>1 cigar per day)
* Positive for hepatitis B, hepatitis C or HIV infection
* History of hypersensitivity or severe drug reaction
* Participation in an investigational drug or device study within three months before the first drug administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2011-002053-54

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP25752

Identifier Type: -

Identifier Source: org_study_id