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A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers

NCT ID: NCT01345942

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-06-30

Brief Summary

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This open label, two period, crossover study will evaluate the safety and the effect of food on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy subjects will be randomized to receive a single oral dose of RO5428029 with or without food, with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after last dose. Anticipated time on study will be up to 21 days.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A food

Group Type EXPERIMENTAL

RO5428029

Intervention Type DRUG

Single oral dose

B without food

Group Type EXPERIMENTAL

RO5428029

Intervention Type DRUG

Single oral dose

Interventions

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RO5428029

Single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers, 18 to 60 years of age inclusive
* Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive, and a minimum weight of 45 kg
* Female subjects must be surgically sterile or post-menopausal
* Male subjects and their partners of child-bearing potential must use 2 methods of contraception (one of which a barrier method) for the duration of the study and for at least 70 days after the last dose

Exclusion Criteria

* Pregnant or lactating women, and male partners of women who are pregnant or lactating
* Women with reproductive potential
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average; alcohol consumption will be prohibited at least 48 hours before screening
* Positive test for drugs of abuse
* History or symptoms of any significant disease
* Positive for HIV, hepatitis B or hepatitis C infection
* Participation in an investigational drug or device study within 3 months prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PP25583

Identifier Type: -

Identifier Source: org_study_id