A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers - Full Text View

Purpose

This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its metabolite BCI-632 and several new pro-drugs in healthy male subjects.

Condition	Intervention	Phase
Healthy	Drug: BCI-838 Drug: BCI-1038, BCI-1206 & BCI-1283	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetic and Food Effect of BCI-838; and, An Open-Label Minidose Bioavailability Study to Compare Several BCI-632 Pro-drug Candidates in Healthy Male Subjects

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by BrainCells Inc.:

Primary Outcome Measures:

Safety [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.

Secondary Outcome Measures:

Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632 [ Time Frame: predose and at specified intervals up to 72 hours post-dose ] [ Designated as safety issue: No ]
The pharmacokinetics of BCI-838 and its metabolite BCI-632, an assessment of the dose proportionality of the pharmacokinetics following single ascending doses of BCI-838, and an evaluation of the relative bioavailability and pharmacokinetics of the metabolite BCI-632 following oral administration of several new pro-drug candidates will be completed by assessment of Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel.

Enrollment:	31
Study Start Date:	October 2011
Study Completion Date:	February 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BCI-838 Food Effect Dosing Arm 1 Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.	Drug: BCI-838 BCI-838 administered as a single 30 mg oral dose or matching placebo under fasted and fed conditions in a crossover design
Experimental: BCI-838 Fasted Dosing (100 & 300 mg) Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.	Drug: BCI-838 BCI-838 100 mg and 300 mg or matching placebo administered as single oral doses under fasted conditions in a sequential design
Experimental: BCI-1038, BCI-1206 & BCI-1283 Six subjects will be enrolled, all 6 will receive single doses of BCI-1038, BCI-1206 and BCI-1283.	Drug: BCI-1038, BCI-1206 & BCI-1283 Three new pro-drugs administered as a 1 mg single oral doses under fasted conditions in a sequential design
Experimental: BCI-838 Fasted Dosing (900 mg) Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.	Drug: BCI-838 BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions

Detailed Description:

The first phase of this study will evaluate the safety and tolerability of BCI-838 following oral administration of single doses of BCI-838 in healthy male subjects. The pharmacokinetics of BCI-838 and its metabolite BCI-632 following single ascending doses of BCI-838 will be evaluated, as will the effect of food on the pharmacokinetics of BCI-838 and its metabolite following single oral doses of BCI-838 in healthy male subjects.

The second phase of this study will evaluate and compare the relative bioavailability and PK of the metabolite BCI-632 following single oral administration of several new pro-drug candidates in healthy male subjects.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult male healthy volunteer, 18-55 years of age
Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546051

Locations

Netherlands
PRA International
Zuidlaren, Netherlands, 9471 GP

Sponsors and Collaborators

BrainCells Inc.

Investigators

Principal Investigator:

Principal Investigator

PRA International

More Information

No publications provided

Responsible Party:	BrainCells Inc.
ClinicalTrials.gov Identifier:	NCT01546051 History of Changes
Other Study ID Numbers:	BCI-632-CL-002
Study First Received:	February 24, 2012
Last Updated:	March 6, 2012
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by BrainCells Inc.:

metabotropic glutamate receptors 2 and 3
antagonist
mGluR
ketamine
BDNF

Depression
Major Depressive Disorder
Mood Disorder
Treatment Resistant Depression
Phase 1 safety, tolerability and pharmacokinetics study

ClinicalTrials.gov processed this record on May 22, 2013