A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects

Hoffmann-La Roche0 sites36 target enrollmentJuly 2012

ConditionsHealthy Volunteer

InterventionsPlacebo RO5508887

DrugsPlacebo RO5508887

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 36
Primary Endpoint: Safety: incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

September 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult healthy volunteers, \>/=18 years of age
•Body mass index (BMI) between 18 and 30 kg/m2 inclusive
•Use of adequate contraception methods or surgically sterile

Exclusion Criteria

•Evidence of active or chronic disease
•Regular consumption of drugs of abuse
•Regular smoker (\>5 cigarettes per day)
•Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
•History of significant allergic reactions
•Abnormal blood pressure
•Clinical significant abnormalities (e.g., cardiovascular, laboratory values)

Arms & Interventions

Placebo

Intervention: Placebo

RO5508887

Intervention: RO5508887

Outcomes

Primary Outcomes

Safety: incidence of adverse events

Time Frame: 30 days

Secondary Outcomes

Correlation of the age on pharmacokinetics of RO5508887(30 days)
Pharmacokinetics: plasma levels of RO5508887(Predose and up to 144 hours post last dose, and at follow-up)
Correlation of the age on pharmacodynamics of RO5508887(30 days)
Pharmacodynamics: Plasma levels of amyloid deposition markers(Predose and up to 144 hours post last dose)
Correlation of the age on safety of RO5508887(30 days)