A Single-Center Study of RO5508887 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664143

Enrollment

Registered

2012-08-14

Start date

2012-07-31

Completion date

2012-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGPlacebo

Multiple doses of placebo

DRUGRO5508887

Multiple doses of RO5508887

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Safety: incidence of adverse events	30 days

Secondary

Measure	Time frame
Correlation of the age on pharmacokinetics of RO5508887	30 days
Correlation of the age on pharmacodynamics of RO5508887	30 days
Pharmacokinetics: plasma levels of RO5508887	Predose and up to 144 hours post last dose, and at follow-up
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026