A Phase 1, Dose Escalation Study to Evaluate the safety tolerability and pharmacokinetics of single oral doses of ELND007 in healthy elderly subjects.

Completed

• Conditions: Alzheimer; dementia

• Registration Number: NL-OMON34459
• Lead Sponsor: Elan Pharma

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: 42

Inclusion Criteria

Healthy elderly volunteers, between 55 and 80 years of age, BMI is <32 kg/m2, body weight should be * 125 kg, non-smoker or or used tobacco products within the last 5 years
* female subjects should be at least 2 years post-menopausal or surgically sterile (hysterectomy or sterilization);

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 within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the past 10 months prior to the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics : plasma Aß concentrations<br /><br>Pharmacokinetics : plasma ELND007 concentrations, pharmacokinetic parameters<br /><br>Safety : adverse events, vital signs, ECG-parameters,<br /><br>laboratory parameters, physical examination, telemetry</p><br>

Secondary Outcome Measures

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