A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC AND FOOD EFFECT OF BCI 838 AND AN OPEN-LABEL MINIDOSE BIOAVAILABILITY STUDY TO COMPARE SEVERAL BCI-632 PRO-DRUG CANDIDATES IN HEALTHY MALE SUBJECTS

Completed

• Conditions: depression; mood disorders; 10027946

• Registration Number: NL-OMON35311
• Lead Sponsor: BrainCells 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: 30

Inclusion Criteria

- Healthy male
- 18-55 years of age, 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 60 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 the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Criteria for evaluation<br /><br>Safety: AEs, vital signs, 12-lead ECG, clinical laboratory and physical<br /><br>examination<br /><br>PK: plasma concentrations of BCI-838 and metabolite BCI-632; PK parameters in<br /><br>plasma</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>