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
1 other identifier
interventional
97
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2010
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 25, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedNovember 2, 2016
November 1, 2016
June 25, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s)
Day 1 to Day 4
Secondary Outcomes (1)
Safety and tolerability: Adverse events, laboratory parameters, ECG
Day 1 to Day 10
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Glendale, California, 91206, United States
Unknown Facility
Eatontown, New Jersey, 07724, United States
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2010
First Posted
June 29, 2010
Study Start
June 1, 2010
Study Completion
August 1, 2010
Last Updated
November 2, 2016
Record last verified: 2016-11