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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO5428029

• Registration Number: NCT01345942
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study Start: 2011-05
• Study First Posted: 2011-05-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A food	RO5428029	-
B without food	RO5428029	-

Primary Outcome Measures

Name	Time	Method
Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration	72 hours

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	approximately 3 weeks