A Study of RO5267683 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398241
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO5267683 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: Active Drug: RO5267683
Multiple ascending doses

Placebo Comparator: Placebo Drug: placebo
Multiple ascending doses

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Plasma concentrations [ Time Frame: 14 weeks ]
  2. Pharmacokinetics: Urine concentrations [ Time Frame: 4 weeks ]
  3. Lipid levels in the blood [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398241

Strasbourg, France, 67064
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01398241     History of Changes
Other Study ID Numbers: BP25214
2011-000600-17 ( EudraCT Number )
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016