A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 8/3/2016 |
| Start Date: | May 2011 |
| End Date: | June 2011 |
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
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.
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.
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
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