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CompletedNCT01548703Updated May 9, 2012

A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers

A Phase 1 interventional study of BCI-838 and BCI-838 in Healthy, sponsored by BrainCells Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-09.

Sponsored by BrainCells Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BCI-838 and its metabolite BCI-632 in healthy male and female subjects.

Read the detailed description

This study will evaluate the safety and tolerability following oral administration of multiple doses of BCI-838 in healthy male and female subjects. The pharmacokinetic profile of multiple oral doses of BCI-838 in healthy male and female subjects will also be assessed. In addition, the pharmacodynamic effects of BCI-838 on the central nervous system using quantitative electroencephalogram analysis will be studied.

02

Conditions studied

  • Healthy

Keywords

  • metabotropic glutamate receptors 2 and 3
  • antagonist
  • mGluR
  • ketamine
  • BDNF
  • Depression
  • Major Depressive Disorder
  • Treatment Resistant Depression
  • Mood Disorder
  • Phase 1 safety, tolerability and pharmacokinetics study
03

In context

Lead sponsor

BrainCells Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult male and female healthy volunteers, 18-55 years of age
  • Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
  • Female subjects must have a negative pregnancy test at screening and admission. Females of childbearing potential (not at least 2 years postmenopausal or surgically sterile) must be using a reliable, medically acceptable form of contraception for at least 30 days prior to the screening visit and must agree to continue such use throughout the duration of the study and for 3 months after the final dose of study drug.
  • 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    BCI-838 Dosing Arm 1

    Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.

    Drug: BCI-838

  • Experimental
    BCI-838 Dosing Arm 2

    Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.

    Drug: BCI-838

  • Experimental
    BCI-838 Dosing Arm 3

    Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.

    Drug: BCI-838

Interventions

  • DrugBCI-838

    BCI-838 100 mg or matching placebo administered once daily for 7 days

  • DrugBCI-838

    BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.

  • DrugBCI-838

    BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.

06

What researchers measure

Primary outcomes

  1. Safety

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

    Time frame: 14 days

Secondary outcomes

  1. Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632

    The pharmacokinetics of BCI-838 and its metabolite BCI-632 will be completed by assessment of Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel.

    Time frame: predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose)

  2. Quantitative EEG (qEEG) assessments

    The pharmacodynamic effects of BCI-838 on the central nervous system will be evaluated using quantitative electroencephalogram analysis.

    Time frame: predose, and at specified timepoints during the 7-day dosing period

07

Study locations

1 site
  • PRA International
    Zuidlaren, 9471 GP, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01548703
Lead sponsor
BrainCells Inc.
Responsible party
Sponsor
First posted
Mar 8, 2012
Start date
Feb 2012
Primary completion
Apr 2012
Completion
Apr 2012
Last update
May 9, 2012

Study contacts

Salah Hadi, MD
principal investigator · PRA Health Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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BrainCells Inc.

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