A Study of RO5267683 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01398241
First received: July 14, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.


Condition Intervention Phase
Healthy Volunteer
Drug: RO5267683
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma concentrations [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Urine concentrations [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Lipid levels in the blood [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: RO5267683
Multiple ascending doses
Placebo Comparator: Placebo Drug: placebo
Multiple ascending doses

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects, 18 to 45 years of age,
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening
  • Female subjects must be surgically sterile or post-menopausal
  • Male subjects must use a barrier method of contraception for the duration of the study and for 90 days after the last dose

Exclusion Criteria:

  • History or evidence of any clinically significant disease or disorder
  • Administration of an investigational drug or device within 3 months prior to dosing on Day 1
  • Positive for hepatitis B, hepatitis C or HIV at screening
  • Subjects on hormone replacement therapy who have not been receiving a stable dose for at least 2 months prior to start of dosing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398241

Locations
France
Strasbourg, France, 67064
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: NCT01398241     History of Changes
Other Study ID Numbers: BP25214, 2011-000600-17
Study First Received: July 14, 2011
Last Updated: April 7, 2014
Health Authority: France: AFSSAPS

ClinicalTrials.gov processed this record on April 17, 2014