A DOUBLE-BLIND, ASCENDING SINGLE AND MULTIPLE DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND FOOD EFFECT STUDY OF EVP 6308 IN HEALTHY VOLUNTEERS.

Completed

• Conditions: delusions; schizophrenia; 10039628

• Registration Number: NL-OMON37679
• Lead Sponsor: EnVivo Pharmaceuticals, Inc.

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: 70

Inclusion Criteria

Age : SAD part (Groups 1-3) and MAD part (Groups 4-7): 18-65 years, inclusive;
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: AEs, vital signs, 12-lead ECG, clinical laboratory, prolactin, inhibin<br /><br>B and physical examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PK : plasma concentrations of EVP 6308 and select metabolites, plasma and urine<br /><br>PK parameters; metabolite profiling of plasma if conducted, will be reported<br /><br>separately.<br /><br>PD : qEEG, Bond and Lader VAS and DSST</p><br>