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

Hoffmann-La Roche0 sites97 target enrollmentJune 2010

ConditionsHealthy Volunteer

InterventionsRO5024048 Placebo

DrugsPlacebo RO5024048

Overview

Phase: Phase 1
Intervention: RO5024048
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 97
Primary Endpoint: Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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 either single oral doses of RO5024048 or placebo. Follow-up is 7-10 days.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

August 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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