A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01152671
First received: June 25, 2010
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetics of RO5024048. Japanese and Caucasian healthy v olunteers will be randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10 days.


Condition Intervention Phase
Healthy Volunteer
Drug: Placebo
Drug: RO5024048
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s) [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability: Adverse events, laboratory parameters, ECG [ Time Frame: Day 1 to Day 10 ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: June 2010
Estimated Study Completion Date: August 2010
Arms Assigned Interventions
Experimental: Arm 1 Drug: RO5024048
single oral dose
Placebo Comparator: Arm 2 Drug: Placebo
single oral dose

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152671

Locations
United States, California
Glendale, California, United States, 91206
United States, New Jersey
Eatontown, New Jersey, United States, 07724
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01152671     History of Changes
Other Study ID Numbers: PP25311
Study First Received: June 25, 2010
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014