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

May 7, 2012 updated by: BrainCells Inc.

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BCI 838 in Healthy Adult Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zuidlaren, Netherlands, 9471 GP
        • PRA International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 2
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
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-838 100 mg or matching placebo administered once daily for 7 days
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 14 days
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose)
Quantitative EEG (qEEG) assessments
Time Frame: predose, and at specified timepoints during the 7-day dosing period
The pharmacodynamic effects of BCI-838 on the central nervous system will be evaluated using quantitative electroencephalogram analysis.
predose, and at specified timepoints during the 7-day dosing period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrainCells Inc.

Investigators

  • Principal Investigator: Salah Hadi, MD, PRA Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 7, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCI-632-CL-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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