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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCI-838 Food Effect Dosing Arm 1 | Experimental | Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo. |
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| BCI-838 Fasted Dosing (100 & 300 mg) | Experimental | Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo. |
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| 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. |
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| BCI-838 Fasted Dosing (900 mg) | Experimental | Eight subjects will be enrolled, 6 will receive BCI-838 and 2 will receive matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety will be evaluated by adverse events, vital signs, ECG, clinical labs, and physical exam. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | PRA Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Zuidlaren | 9471 GP | Netherlands |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D019964 | Mood Disorders |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000629763 | BCI-838 |
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| BCI-838 | Drug | BCI-838 administered as a single 30 mg oral dose or matching placebo under fasted and fed conditions in a crossover design |
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| 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-838 | Drug | BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions |
|
| predose and at specified intervals up to 72 hours post-dose |