A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01461967
First received: October 24, 2011
Last updated: April 7, 2014
Last verified: April 2014

October 24, 2011
April 7, 2014
September 2011
December 2011   (final data collection date for primary outcome measure)
Safety/tolerability: Incidence of adverse events [ Time Frame: up to approximately 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01461967 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Plasma concentrations of RO5508887 [ Time Frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Urine levels of RO5508887 [ Time Frame: predose to 72 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42) [ Time Frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose ] [ Designated as safety issue: No ]
  • Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887 [ Time Frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
A Single-Center, Randomized, Double-Blind, Single and Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food) and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects.

This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Healthy Volunteer
  • Drug: RO5508887
    Single ascending doses
  • Drug: Placebo
    Single ascending doses
  • Drug: RO5508887
    Single doses
  • Experimental: Part 1a
    Intervention: Drug: RO5508887
  • Placebo Comparator: Part 1b
    Intervention: Drug: Placebo
  • Experimental: Part 2
    Intervention: Drug: RO5508887
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease
  • Body Mass Index (BMI) 18 to 30 kg/m2 inclusive
  • Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose

Exclusion Criteria:

  • Suspicion of regular consumption of drugs of abuse
  • Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
  • Positive for hepatitis B, hepatitis C or HIV infection
  • History of hypersensitivity or severe drug reaction
  • Participation in an investigational drug or device study within three months before the first drug administration
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01461967
WP25752, 2011-002053-54
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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