A Study of RO4995819 in Healthy Elderly Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: RO4995819

Study type: Interventional

Funder types: Industry

Identifiers

NCT01457664

BP25589

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

RO4995819

Experimental group

Treatment:

Drug: RO4995819