A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers

Ketamine

Brief Summary

This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its metabolite BCI-632 and several new pro-drugs in healthy male subjects.

Intervention / Treatment

  • BCI-838 (DRUG)
    BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions
  • BCI-1038, BCI-1206 & BCI-1283 (DRUG)
    Three new pro-drugs administered as a 1 mg single oral doses under fasted conditions in a sequential design

Condition or Disease

  • Healthy

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 31 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Oct 01, 2011
    Primary Completion: Jan 01, 2012 ACTUAL
    Completion Date: Feb 01, 2012 ACTUAL
    Study First Posted: Mar 07, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 06, 2012

    Sponsors / Collaborators

    Lead Sponsor: BrainCells Inc.
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Zuidlaren, Drenthe, Netherlands

    The first phase of this study will evaluate the safety and tolerability of BCI-838 following oral administration of single doses of BCI-838 in healthy male subjects. The pharmacokinetics of BCI-838 and its metabolite BCI-632 following single ascending doses of BCI-838 will be evaluated, as will the effect of food on the pharmacokinetics of BCI-838 and its metabolite following single oral doses of BCI-838 in healthy male subjects.

    The second phase of this study will evaluate and compare the relative bioavailability and PK of the metabolite BCI-632 following single oral administration of several new pro-drug candidates in healthy male subjects.

    Participant Groups

    • Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

    • Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

    • Six subjects will be enrolled, all 6 will receive single doses of BCI-1038, BCI-1206 and BCI-1283.

    • Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Adult male healthy volunteer, 18-55 years of age
    * Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
    * Good general health as determined by medical history and physical examination with no clinically significant medical findings and no clinically relevant medical or surgical history and no acute or ongoing conditions within the past 30 days
    * Able to participate and willing to give written informed consent and to comply with the study restrictions

    Exclusion Criteria:

    * Clinically significant medical abnormality, chronic disease or history or presence of significant pulmonary, gastrointestinal, metabolic, cardiac, hepatic, renal or neurological disorder
    * History or current use of alcohol abuse or drug addiction
    * Participation in a drug study within 60 days prior to drug administration.
    * Participation in more than 3 other drug studies in the 10 months preceding the start of this study
    * Donation or blood loss of more than 50 mL of blood within 60 days prior to the first drug administration. Donation of more than 1.5 liters of blood in the 10 months preceding the start of this study
    * Illness within 5 days prior to drug administration

    Primary Outcomes

    • Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.

    Secondary Outcomes

    • The pharmacokinetics of BCI-838 and its metabolite BCI-632, an assessment of the dose proportionality of the pharmacokinetics following single ascending doses of BCI-838, and an evaluation of the relative bioavailability and pharmacokinetics of the metabolite BCI-632 following oral administration of several new pro-drug candidates will be completed by assessment of Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel.

    More Details

    NCT Number: NCT01546051
    Other IDs: BCI-632-CL-002
    Study URL: https://clinicaltrials.gov/study/NCT01546051
    Last updated: Sep 29, 2023