A Study of RO4995819 in Healthy Elderly Volunteers

Hoffmann-La Roche30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteer

Interventions

PlaceboDRUG

Placebo to RO4995819 once daily for 14 days

RO4995819DRUG

RO4995819 doses once daily for 14 days

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Miramar, Florida, United States

Outcomes

Primary Outcomes

Safety (incidence of adverse events)

Time frame: 8 weeks

Secondary Outcomes

Pharmacokinetics: area under the concentration time curve (AUC)

Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 22, 20, 36, 62

Data from ClinicalTrials.gov

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