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

NCT ID: NCT01548703

Last Updated: 2012-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-04-30

Brief 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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BCI-838 Dosing Arm 1

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

Group Type: EXPERIMENTAL

BCI-838

Intervention Type: DRUG

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

BCI-838 Dosing Arm 2

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

Group Type: EXPERIMENTAL

BCI-838

Intervention Type: DRUG

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.

BCI-838 Dosing Arm 3

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

Group Type: EXPERIMENTAL

BCI-838

Intervention Type: DRUG

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.

Interventions

BCI-838

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BrainCells Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salah Hadi, MD

Role: PRINCIPAL_INVESTIGATOR

PRA Health Sciences

Locations

PRA International

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

BCI-632-CL-003

Identifier Type: -

Identifier Source: org_study_id