A Study of RO4995819 in Healthy Elderly Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Drug: RO4995819Drug: Placebo
- Registration Number
- NCT01457664
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
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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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RO4995819 RO4995819 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety (incidence of adverse events) 8 weeks
- Secondary Outcome Measures
Name Time Method 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