A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01152671

Enrollment

Registered

2010-06-29

Start date

2010-06-30

Completion date

2010-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGPlacebo

single oral dose

DRUGRO5024048

single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s)	Day 1 to Day 4

Secondary

Measure	Time frame
Safety and tolerability: Adverse events, laboratory parameters, ECG	Day 1 to Day 10

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026