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: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: RO5024048
Drug: Placebo
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
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: April 7, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014