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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01209221
First received: September 24, 2010
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This placebo-controlled, randomized, observer-blind, dose-ascending study will i nvestigate the safety, tolerability, pharmacokinetics and pharmacodynamics of si ngle and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers w ill be randomized to receive either a single oral dose of RO5271983 or placebo i n the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. T he anticipated time on study treatment is approximately 14 weeks for the SAD par t and up to 8 weeks for the MAD part.


Condition Intervention Phase
Healthy Volunteer
Drug: RO5271983 - SAD
Drug: RO5271983 - MAD
Drug: Placebo - SAD
Drug: Placebo - MAD
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983 [ Time Frame: up to 240 hours ] [ Designated as safety issue: No ]
  • Single ascending dose (SAD): Safety (incidence of adverse events) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Single ascending dose (SAD): Tolerability (e.g. vital signs) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983 [ Time Frame: 17 days ] [ Designated as safety issue: No ]
  • Multiple ascending doses (MAD): Safety (incidence of adverse events) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Multiple ascending doses (MAD): Tolerability (e.g. vital signs) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of food on pharmacokinetics of RO5271983 [ Time Frame: up to 240 hours ] [ Designated as safety issue: No ]
  • Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01209221

Locations
New Zealand
Christchurch, New Zealand, 8011
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: NCT01209221     History of Changes
Other Study ID Numbers: NP25342
Study First Received: September 24, 2010
Last Updated: July 7, 2014
Health Authority: New Zealand: Health and Disability Ethics Committees

ClinicalTrials.gov processed this record on July 23, 2014