A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: RO5024048

• Registration Number: NCT01152671
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Study Completion: 2010-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	RO5024048	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability: Adverse events, laboratory parameters, ECG	Day 1 to Day 10