A Study of RO4995819 in Healthy Elderly Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01457664

Run by

Hoffmann-La Roche

People needed

30

Starts

2011-07-01

Expected to finish

2011-12-01

Last updated by the study team

2016-11-02

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Miramar, Florida, United States

Full record on ClinicalTrials.gov

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