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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO5024048; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
  • New Jersey
    • Eatontown, New Jersey, United States, 07724

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: RO5024048; single oral dose
Placebo Comparator: Arm 2	Drug: Placebo; single oral dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion: December 6, 2022
• Study Completion: August 1, 2010

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PP25311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No