A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01152671

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

48.5

Patients Per Site

24.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: Placebo Drug: RO5024048	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

97 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Official Title:

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

Study Start Date :

Jun 1, 2010

Study Completion Date :

Aug 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: RO5024048

single oral dose

Placebo Comparator: Arm 2

Drug: Placebo

single oral dose

Outcome Measures

Primary Outcome Measures

Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s) [Day 1 to Day 4]

Secondary Outcome Measures

Safety and tolerability: Adverse events, laboratory parameters, ECG [Day 1 to Day 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Glendale	California	United States	91206
2		Eatontown	New Jersey	United States	07724

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01152671

Other Study ID Numbers:

PP25311

First Posted:

Jun 29, 2010

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016