A Study of RO4995819 in Healthy Elderly Volunteers

A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of RO4995819 Following Oral Administration in Healthy Elderly Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01457664

Enrollment

Registered

2011-10-24

Start date

2011-07-31

Completion date

2011-12-31

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 study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.

Interventions

DRUGPlacebo

Placebo to RO4995819 once daily for 14 days

DRUGRO4995819

RO4995819 doses once daily for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Adult healthy volunteer, 65-85 years of age * Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive and a total body weight \>50 kg (110 lbs) * Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion criteria

* Any history or suspicion of drug or alcohol abuse * Clinically significant or unstable cardiovascular or bronchopulmonary diseases, or any type of cancer * History of liver disease * Significant past or present neurological disorder * History of psychiatric disorders * Participation in an investigational drug or device study within 12 weeks prior to screening * Donation of blood over 500 mL within three months prior to screening

Design outcomes

Primary

Measure	Time frame
Safety (incidence of adverse events)	8 weeks

Secondary

Measure	Time frame
Pharmacokinetics: area under the concentration time curve (AUC)	Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 22, 20, 36, 62

Countries

United States

Outcome results

None listed

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