Healthy
Conditions
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
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.
Interventions
DRUGBCI-838
BCI-838 100 mg and 300 mg or matching placebo administered as single oral doses under fasted conditions in a sequential design
DRUGBCI-1038, BCI-1206 & BCI-1283
Three new pro-drugs administered as a 1 mg single oral doses under fasted conditions in a sequential design
Sponsors
BrainCells Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 7 days | Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Netherlands
Outcome results
None listed