NCT01548703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

February 27, 2012

Last Update Submit

May 7, 2012

Conditions

Healthy

Keywords

metabotropic glutamate receptors 2 and 3antagonistmGluRketamineBDNFDepressionMajor Depressive DisorderTreatment Resistant DepressionMood DisorderPhase 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.

    14 days

Secondary Outcomes (2)

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

    predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose)

  • Quantitative EEG (qEEG) assessments

    predose, and at specified timepoints during the 7-day dosing period

Study Arms (3)

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

BCI-838DRUG

BCI-838 100 mg or matching placebo administered once daily for 7 days

BCI-838 Dosing Arm 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA International

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorDepressive Disorder, Treatment-ResistantMood Disorders

Interventions

BCI-838

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMental Disorders

Study Officials

  • Salah Hadi, MD

    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 27, 2012

First Posted

March 8, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

NL(1)