A DOUBLE-BLIND, ASCENDING SINGLE AND MULTIPLE DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND FOOD EFFECT STUDY OF EVP 0962 IN HEALTHY VOLUNTEERS

Completed

• Conditions: Alzheimers Disease; 10009841

• Registration Number: NL-OMON35950
• Lead Sponsor: EnVivo Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

Age : SAD part (Groups 1-3) and MAD part (Groups 4-7): 18-65 years, inclusive; MAD part (Group 8): 66-80 years
BMI : 18.0 * 28.0 kg/m2, inclusive
Gender : healthy male or female subjects; female subjects must be of non-childbearing potential (either surgically sterilized or at least 1 year post-menopausal)

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 the study. In case of donating blood or significant loss of blood within 60 days of the start of drug dosing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>safety<br /><br>tolerability<br /><br>pharmacokinetic<br /><br>pharmacodynamic<br /><br>food effect</p><br>

Secondary Outcome Measures

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