A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592331
First received: April 19, 2012
Last updated: September 22, 2014
Last verified: September 2014

April 19, 2012
September 22, 2014
May 2012
October 2012   (final data collection date for primary outcome measure)
  • Plasma levels of amyloid biomarkers [ Time Frame: Pre-dose and up to fullow up, 8-12 days post dose ] [ Designated as safety issue: No ]
  • Cerebral spinal fluid levels of amyloid biomarkers [ Time Frame: Pre-dose and up to 30 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01592331 on ClinicalTrials.gov Archive Site
  • Safety: Incidence of adverse events [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites) [ Time Frame: Pre-dose and up to 72 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers
A Single-Center, Randomized, Investigator/Subject-Blind, Single Dose, Placebo-Controlled, Parallel Group Study to Investigate the Pharmacodynamic and Pharmacokinetic Behavior of RO5508887 in Plasma and Cerebral Spinal Fluid Following Oral Administration in Healthy Volunteers

This randomized, double-blind, placebo-controlled, parallel group study will eva luate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy voluntee rs. Subjects will be randomized in cohorts to receive single oral doses of eith er RO5508887 or placebo. In-unit period is 6 days.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Healthy Volunteer
  • Drug: Placebo
    Single oral dose
  • Drug: RO5508887
    Single oral dose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: RO5508887
    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
42
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • Must agree to use a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study drug
  • Donation of blood over 500 mL within 6 weeks before drug administration

Exclusion Criteria:

  • Concomitant disease or condition or treatment that could interfere with the conduct of the study or would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • Allergy to lidocaine
  • Suspicion of regular consumption of drug of abuse
  • Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
  • Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
  • Participation in an investigational drug or device study (last administration of study drug or installation of device) within 6 weeks before RO5508887 administration and within 5 mean half-lives of receiving previous investigational drug before RO5508887 administration. In addition, subject cannot participate unless completely recovered from previous invasive or study procedure
  • Donation of blood over 500 mL within 6 weeks before drug administration
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01592331
WP27959
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

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