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

NCT01546051 | Completed Phase 1

• 1 other identifier: BCI-632-CL-002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam.

  7 days

Secondary Outcomes (1)

• Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632

  predose and at specified intervals up to 72 hours post-dose

Study Arms (4)

BCI-838 Food Effect Dosing Arm 1

EXPERIMENTAL

Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

Drug: BCI-838

BCI-838 Fasted Dosing (100 & 300 mg)

EXPERIMENTAL

Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

Drug: BCI-838

BCI-1038, BCI-1206 & BCI-1283

EXPERIMENTAL

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

BCI-838 Fasted Dosing (900 mg)

EXPERIMENTAL

Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo.

Drug: BCI-838

Interventions

BCI-838 DRUG

BCI-838 100 mg and 300 mg or matching placebo administered as single oral doses under fasted conditions in a sequential design

BCI-838 Fasted Dosing (100 & 300 mg)

BCI-1038, BCI-1206 & BCI-1283 DRUG

Three new pro-drugs administered as a 1 mg single oral doses under fasted conditions in a sequential design

BCI-1038, BCI-1206 & BCI-1283

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BrainCells Inc.: lead

Study Sites (1)

PRA International

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Mood Disorders; Depressive Disorder, Treatment-Resistant

Interventions

BCI-838

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mental Disorders

Study Officials

• Principal Investigator

  PRA Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 7, 2012
• Study Start: October 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

NL (1)