A Randomized, Open Label, Single Dose, Two Period, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of RO5428029 Following Oral Administration in Healthy Subjects

Hoffmann-La Roche0 sites12 target enrollmentMay 2011

ConditionsHealthy Volunteer

InterventionsRO5428029

DrugsRO5428029

Overview

Phase: Phase 1
Intervention: RO5428029
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 12
Primary Endpoint: Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

June 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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