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NCT Number: NCT01592331

A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Single oral dose

RO5508887

Drug

Single oral dose

Primary outcomes

  1. Plasma levels of amyloid biomarkers

    Time frame: Pre-dose and up to fullow up, 8-12 days post dose

  2. Cerebral spinal fluid levels of amyloid biomarkers

    Time frame: Pre-dose and up to 30 hours post-dose

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 6 months

  2. Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites)

    Time frame: Pre-dose and up to 72 hours post-dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 7, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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