A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers

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: NCT01209221
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Placebo - MAD Drug: Placebo - SAD Drug: RO5271983 - MAD Drug: RO5271983 - SAD Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 1 Placebo-controlled, Randomized, Observer-blind Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5271983 in Healthy Subjects.
Study Start Date : September 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: 1 Drug: RO5271983 - SAD
Single dose of RO5271983 at each period (for up to 3 periods)
Experimental: 2 Drug: RO5271983 - MAD
Once or twice daily doses of RO5271983 for 14 days
Placebo Comparator: 3 Drug: Placebo - SAD
Single dose of matching placebo to RO5271983 for up to 3 periods
Placebo Comparator: 4 Drug: Placebo - MAD
Once or twice daily doses of matching placebo to RO5271983 for 14 days

Primary Outcome Measures :
  1. Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983 [ Time Frame: up to 240 hours ]
  2. Single ascending dose (SAD): Safety (incidence of adverse events) [ Time Frame: 14 weeks ]
  3. Single ascending dose (SAD): Tolerability (e.g. vital signs) [ Time Frame: 14 weeks ]
  4. Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983 [ Time Frame: 17 days ]
  5. Multiple ascending doses (MAD): Safety (incidence of adverse events) [ Time Frame: 8 weeks ]
  6. Multiple ascending doses (MAD): Tolerability (e.g. vital signs) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Effect of food on pharmacokinetics of RO5271983 [ Time Frame: up to 240 hours ]
  2. Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983 [ Time Frame: 72 hours ]
  3. Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983 [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers, 18-65 years of age
  • Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
  • In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception

Exclusion Criteria:

  • A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
  • Clinical significant abnormalities in laboratory test results
  • Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
  • Smokers of >5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study

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): NCT01209221

New Zealand
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01209221     History of Changes
Other Study ID Numbers: NP25342
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016