A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 20 - 55 |
| Updated: | 8/3/2016 |
| Start Date: | June 2010 |
| End Date: | August 2010 |
A Multiple Center Randomized, Double-Blind, Single-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics Following Oral Administration of RO5024048 in Healthy Japanese and Caucasian Subjects
This randomized, double-blind, placebo-controlled study will assess the safety, tolerability
and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be
randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10
days.
and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be
randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10
days.
Inclusion Criteria:
- Healthy male and female adults, 20 to 55 years of age, inclusive
- Body mass index (BMI) 18 - 30 kg/m2 inclusive
- Non-smoker, or previous smoker who discontinued smoking >/= 6 month prior to study
entry
- Japanese subjects must be first generation: born in Japan, not having lived outside
Japan >5 years, able to trace maternal and paternal Japanese ancestry
- Female subjects of childbearing potential and male subjects and their partners of
childbearing potential must agree to use two forms of contraception
- Agree to abstain from alcohol consumption and from strenuous exercise up to 3 days
before dosing and throughout study (including the follow-up visit)
Exclusion Criteria:
- Positive pregnancy test
- Males whose female partner is pregnant or trying to become pregnant
- Positive urine test for drugs of abuse
- Positive for alcohol
- Positive result on hepatitis B, hepatitis C, or HIV test
- Clinically significant disease or abnormalities in laboratory parameters
- Participation in an investigational drug, biologic or device study within 3 months
before study drug administration
- Donation or loss of any blood over 450 mL within 3 months before study drug
administration
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