Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BrainCells Inc.
ClinicalTrials.gov Identifier:
NCT01548703
First received: February 27, 2012
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: BCI-838
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BCI 838 in Healthy Adult Subjects

Further study details as provided by BrainCells Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.


Secondary Outcome Measures:
  • Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632 [ Time Frame: predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose) ] [ Designated as safety issue: No ]
    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.

  • Quantitative EEG (qEEG) assessments [ Time Frame: predose, and at specified timepoints during the 7-day dosing period ] [ Designated as safety issue: No ]
    The pharmacodynamic effects of BCI-838 on the central nervous system will be evaluated using quantitative electroencephalogram analysis.


Enrollment: 30
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
BCI-838 100 mg or matching placebo administered once daily for 7 days
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
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.
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548703

Locations
Netherlands
PRA International
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
BrainCells Inc.
Investigators
Principal Investigator: Salah Hadi, MD PRA Health Sciences
  More Information

No publications provided

Responsible Party: BrainCells Inc.
ClinicalTrials.gov Identifier: NCT01548703     History of Changes
Other Study ID Numbers: BCI-632-CL-003
Study First Received: February 27, 2012
Last Updated: May 7, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by BrainCells Inc.:
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

ClinicalTrials.gov processed this record on November 23, 2014