A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01152671

Run by

Hoffmann-La Roche

People needed

97

Starts

2010-06-01

Expected to finish

2010-08-01

Last updated by the study team

2016-11-02

Who can join

Age: 20 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Glendale, California, United States
• Study site — Eatontown, New Jersey, United States

Full record on ClinicalTrials.gov

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