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A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

NCT ID: NCT01152671

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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

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This randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10 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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Arm 1

Group Type EXPERIMENTAL

RO5024048

Intervention Type DRUG

single oral dose

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single oral dose

Interventions

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Placebo

single oral dose

Intervention Type DRUG

RO5024048

single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female adults, 20 to 55 years of age, inclusive
* Body mass index (BMI) 18 - 30 kg/m2 inclusive
* Non-smoker, or previous smoker who discontinued smoking \>/= 6 month prior to study entry
* Japanese subjects must be first generation: born in Japan, not having lived outside Japan \>5 years, able to trace maternal and paternal Japanese ancestry
* Female subjects of childbearing potential and male subjects and their partners of childbearing potential must agree to use two forms of contraception
* Agree to abstain from alcohol consumption and from strenuous exercise up to 3 days before dosing and throughout study (including the follow-up visit)

Exclusion Criteria

* Positive pregnancy test
* Males whose female partner is pregnant or trying to become pregnant
* Positive urine test for drugs of abuse
* Positive for alcohol
* Positive result on hepatitis B, hepatitis C, or HIV test
* Clinically significant disease or abnormalities in laboratory parameters
* Participation in an investigational drug, biologic or device study within 3 months before study drug administration
* Donation or loss of any blood over 450 mL within 3 months before study drug administration
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 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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Glendale, California, United States

Site Status

Eatontown, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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PP25311

Identifier Type: -

Identifier Source: org_study_id