Rising Single Dose Safety, Tolerability and Pharmacokinetic Study of SCH 900229 in Healthy Adult Subjects

Completed

• Conditions: Alzheimer's disease; 10009841

• Registration Number: NL-OMON34885
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics: A*40 concentrations in plasma<br /><br>Pharmacokinetics: SCH 900229 concentrations in plasma, metabolite profiling in<br /><br>plasma and urine, pharmacokinetic parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters<br /><br>(including Hes 1 gene expression and PHF-based Notch signalling), physical<br /><br>examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>