A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING MULTIPLE DOSE, SAFETY, TOLERABILITY PHARMACODYNAMIC AND PHARMACOKINETIC STUDY OF BCI 838 IN HEALTHY ADULT SUBJECTS

Completed

• Conditions: depression; mood disorders; 10027946

• Registration Number: NL-OMON37895
• Lead Sponsor: BrainCells 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: 30

Inclusion Criteria

Healthy male and female subjects
Age: 18 * 55 years, inclusive
BMI: 18 * 30 kg/m2, inclusive
Non smoker or moderate smoker (*5 cigarettes per day)

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerabilty of BCI-838</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic of BCI-838 by analysis of plasma concentrations of BCI-838 and<br /><br>metabolite BCI-632<br /><br>and Pharmacodynamic of BCI-838 by analysis/registration of brain activity (EEG) </p><br>