A Multiple Ascending Dose Study of BCI-838 in Healthy Vol... | NCT01548703

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

NCT01548703

Sponsor

BrainCells Inc.

Status

Completed

Last Update Posted

May 9, 2012Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

BCI-838
BCI-838
BCI-838

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Feb 27, 2012

First Submission Date that Met QC Criteria

Mar 6, 2012

First Posted Date

Mar 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2012

Last Update Posted Date

May 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BCI-838 Dosing Arm 1	Experimental	Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.	Drug: BCI-838
BCI-838 Dosing Arm 2	Experimental	Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.	Drug: BCI-838
BCI-838 Dosing Arm 3	Experimental	Ten subjects will be enrolled, 8 will receive BCI-838 and 2 will receive matching placebo.	Drug: BCI-838

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BCI-838	Drug	BCI-838 100 mg or matching placebo administered once daily for 7 days	BCI-838 Dosing Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Salah Hadi, MD	PRA Health Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
PRA International		Zuidlaren		9471 GP	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D003865	Depressive Disorder, Major
D061218	Depressive Disorder, Treatment-Resistant
D019964	Mood Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D003866	Depressive Disorder
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided