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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO5428029

Study type

Interventional

Funder types

Industry

Identifiers

NCT01345942

PP25583

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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