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A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers

NCT ID: NCT01209221

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-10-31

Brief Summary

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This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

RO5271983 - SAD

Intervention Type DRUG

Single dose of RO5271983 at each period (for up to 3 periods)

2

Group Type EXPERIMENTAL

RO5271983 - MAD

Intervention Type DRUG

Once or twice daily doses of RO5271983 for 14 days

3

Group Type PLACEBO_COMPARATOR

Placebo - SAD

Intervention Type DRUG

Single dose of matching placebo to RO5271983 for up to 3 periods

4

Group Type PLACEBO_COMPARATOR

Placebo - MAD

Intervention Type DRUG

Once or twice daily doses of matching placebo to RO5271983 for 14 days

Interventions

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Placebo - MAD

Once or twice daily doses of matching placebo to RO5271983 for 14 days

Intervention Type DRUG

Placebo - SAD

Single dose of matching placebo to RO5271983 for up to 3 periods

Intervention Type DRUG

RO5271983 - MAD

Once or twice daily doses of RO5271983 for 14 days

Intervention Type DRUG

RO5271983 - SAD

Single dose of RO5271983 at each period (for up to 3 periods)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers, 18-65 years of age
* Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
* In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception

Exclusion Criteria

* A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
* Clinical significant abnormalities in laboratory test results
* Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
* Smokers of \>5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Christchurch, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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NP25342

Identifier Type: -

Identifier Source: org_study_id