Clinical trial NCT01548703: A Multiple Ascending Dose Study of BCI-838 in Healthy Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BCI 838 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: metabotropic glutamate receptors 2 and 3
antagonist
mGluR
ketamine
BDNF
Depression
Major Depressive Disorder
Treatment Resistant Depression
Mood Disorder
Phase 1 safety, tolerability and pharmacokinetics study
Lead sponsor: BrainCells Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety
timeFrame: 14 days
Secondary outcomes:
measure: Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632
timeFrame: predose, at specified timepoints during the 7-day dosing period, and at Day 10 (72 hours post-dose)
measure: Quantitative EEG (qEEG) assessments
timeFrame: predose, and at specified timepoints during the 7-day dosing period
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: PRA International
Study officials:
affiliation: PRA Health Sciences
name: Salah Hadi, MD
role: PRINCIPAL_INVESTIGATOR
References: