Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-30 @ 12:21 AM
Study NCT ID:
NCT01548703
Status:
COMPLETED
Last Update Posted:
2012-05-09
First Post:
2012-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers
Sponsor:
BrainCells Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BCI 838 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: