A Single-Center Study of RO5508887 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: RO5508887

• Registration Number: NCT01664143
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
RO5508887	RO5508887	-

Primary Outcome Measures

Name	Time	Method
Safety: incidence of adverse events	30 days

Secondary Outcome Measures

Name	Time	Method
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