Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 3, 2014
Last verified: November 2014

September 24, 2010
November 3, 2014
September 2010
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01209221 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: Placebo - MAD
    Once or twice daily doses of matching placebo to RO5271983 for 14 days
  • Drug: Placebo - SAD
    Single dose of matching placebo to RO5271983 for up to 3 periods
  • Drug: RO5271983 - MAD
    Once or twice daily doses of RO5271983 for 14 days
  • Drug: RO5271983 - SAD
    Single dose of RO5271983 at each period (for up to 3 periods)
  • Experimental: 1
    Intervention: Drug: RO5271983 - SAD
  • Experimental: 2
    Intervention: Drug: RO5271983 - MAD
  • Placebo Comparator: 3
    Intervention: Drug: Placebo - SAD
  • Placebo Comparator: 4
    Intervention: Drug: Placebo - MAD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01209221
NP25342
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP