Clinical trial NCT01546051: A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers
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
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
Mood Disorder
Treatment Resistant Depression
Phase 1 safety, tolerability and pharmacokinetics study
Lead sponsor: BrainCells Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 31
Sex: MALE
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 and pharmacokinetics of BCI-838, its metabolite BCI-632 and several new pro-drugs in healthy male subjects.

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 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

Primary outcomes:
measure: Safety
timeFrame: 7 days
Secondary outcomes:
measure: Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632
timeFrame: predose and at specified intervals up to 72 hours post-dose
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: PRA International
Study officials:
affiliation: PRA Health Sciences
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: