Healthy Volunteer
Conditions
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.
Interventions
DRUGRO5428029
Single oral dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | approximately 3 weeks |
Countries
United States
Outcome results
None listed