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: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: Placebo
Drug: RO5508887
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Single oral dose
Experimental: RO5508887 Drug: RO5508887
Single oral dose

  Eligibility

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

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
  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: NCT01592331

Locations
United States, California
Glendale, California, United States, 91206
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: NCT01592331     History of Changes
Other Study ID Numbers: WP27959
Study First Received: April 19, 2012
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014