Status:
COMPLETED
A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01152671
Start Date
June 1 2010
End Date
August 1 2010
Last Update
November 2 2016
Active Locations (2)
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1
Glendale, California, United States, 91206
2
Eatontown, New Jersey, United States, 07724