A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT01345942
- Run by
- Hoffmann-La Roche
- People needed
- 12
- Starts
- 2011-05-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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