A Study of RO4995819 in Healthy Elderly Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:65 - 85
Updated:8/3/2016
Start Date:July 2011
End Date:December 2011

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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.

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.


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
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