Alzheimer's disease
Conditions
Interventions
Study Medication:
Active substance: SCH 900229
Activity: *-secretase (GS) inhibitor
Indication: Alzheimer*s disease (AD)
Strength: 0.1 and 1 mg/mL (oral solution)
2 mg (powder capsule) and 12 mg
(liquid emulsion capsule)
Dosage form: oral solution, powder capsule (Period 3) and liquid emulsion
capsule (Period 3)
Treatments:
Cohort 1
Period 1: a single oral
Sponsors
Schering-Plough
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy men and women, between 30 and 65 years of age (inclusive), BMI between 18 and 30 kg/m2, no more cigarettes than 10 per day, female have been surgically sterilized for at least 3 months before screening or post-menopausal for at least one year.
Exclusion criteria
Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor (50 mL or more) within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months preceding the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: A*40 concentrations in plasma Pharmacokinetics: SCH 900229 concentrations in plasma, metabolite profiling in plasma and urine, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters (including Hes 1 gene expression and PHF-based Notch signalling), physical examination | — |
Countries
Netherlands
Outcome results
None listed