A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers

NCT01592331 | Completed Phase 1

• 1 other identifier: WP27959
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Plasma levels of amyloid biomarkers

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

• Cerebral spinal fluid levels of amyloid biomarkers

  Pre-dose and up to 30 hours post-dose

Secondary Outcomes (2)

• Safety: Incidence of adverse events

  approximately 6 months

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

  Pre-dose and up to 72 hours post-dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

RO5508887

EXPERIMENTAL

Drug: RO5508887

Interventions

Placebo DRUG

Single oral dose

Placebo

RO5508887 DRUG

Single oral dose

RO5508887

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: May 7, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)