A Single-Center Study of RO5508887 in Healthy Volunteers
- Registration Number
- NCT01664143
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Adult healthy volunteers, >/=18 years of age
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive
- Use of adequate contraception methods or surgically sterile
Exclusion Criteria
- Evidence of active or chronic disease
- Regular consumption of drugs of abuse
- Regular smoker (>5 cigarettes per day)
- Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
- History of significant allergic reactions
- Abnormal blood pressure
- Clinical significant abnormalities (e.g., cardiovascular, laboratory values)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - RO5508887 RO5508887 -
- Primary Outcome Measures
Name Time Method Safety: incidence of adverse events 30 days
- Secondary Outcome Measures
Name Time Method Correlation of the age on pharmacokinetics of RO5508887 30 days Pharmacokinetics: plasma levels of RO5508887 Predose and up to 144 hours post last dose, and at follow-up Correlation of the age on pharmacodynamics of RO5508887 30 days Pharmacodynamics: Plasma levels of amyloid deposition markers Predose and up to 144 hours post last dose Correlation of the age on safety of RO5508887 30 days