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A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers

NCT ID: NCT01864226

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-01-31

Brief Summary

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This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive either RO5545965 or matching placebo daily for 12 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 ascending doses

RO5545965

Group Type EXPERIMENTAL

RO5545965

Intervention Type DRUG

Multiple ascending doses

Interventions

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RO5545965

Multiple ascending doses

Intervention Type DRUG

placebo

Multiple ascending doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult male and female volunteers, 18 - 64 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Female subject must be post-menopausal or surgically sterile
* Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug

Exclusion Criteria

* History of any clinically significant disease or disorder
* Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Clinically significant abnormalities in laboratory test results
* Suspicion of regular consumption of drug of abuse
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug or device study within 90 days prior to screening
* Regular smoker (\>5 cigarettes, \>1 pipeful or \>1 cigar per day)
* History of clinically significant hypersensitivity or allergic drug reactions
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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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Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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BP28845

Identifier Type: -

Identifier Source: org_study_id