View Clinical Trial (Medical Research Study)

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

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Conditions:		Healthy Volunteer
Purpose:		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.
Study Summary:
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
NCT ID:		NCT01345942
Primary Contact:		Study Director Clinical Trials Hoffmann-La Roche
Backup Contact:		N/A
Location Contact:		San Antonio, Texas 78209 United States There is no listed contact information for this specific location. Site Status: N/A

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