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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548703
• Other study ID #: BCI-632-CL-003
• Status: Completed
• Phase: Phase 1
• First received: February 27, 2012
• Last updated: May 7, 2012
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: BrainCells Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BCI-838
BCI-838 100 mg or matching placebo administered once daily for 7 days
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	PRA International	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
BrainCells Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.	14 days	No
Secondary	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.	predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose)	No
Secondary	Quantitative EEG (qEEG) assessments	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	No