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A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers - NCT01152671-91206(Clinical Trial 680919)



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City:  Glendale
State:  
CA
Zip Code: 91206
Conditions: Healthy Volunteer
Purpose: 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.
Study summary:
Criteria: 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
Study is available at:
Glendale, CA 91206
United States

Primary Contact:
Please reference Study ID Number: PP25311
Email: genentechclinicaltrials@druginfo.com
Phone: 888-662-6728 (U.S. Only)
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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