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A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592331
First Posted: May 7, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.

Subjects will be randomized in cohorts to receive single oral doses of either 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Cerebral spinal fluid levels of amyloid biomarkers [ Time Frame: Pre-dose and up to 30 hours post-dose ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 6 months ]
  • Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites) [ Time Frame: Pre-dose and up to 72 hours post-dose ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01592331     History of Changes
Other Study ID Numbers: WP27959
First Submitted: April 19, 2012
First Posted: May 7, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016