A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO5024048

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01152671

PP25311

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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