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This is single center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of BPN-14967 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (fasted condition) | Experimental | 10 mg BPN-14967 or placebo |
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| Cohort 2 (fasted condition) | Experimental | 25 mg BPN-14967 or placebo |
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| Cohort 3 (fasted condition) | Experimental | 50 mg BPN-14967 or placebo |
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| Cohort 4 (fed condition) | Experimental | 10 mg BPN-14967 or placebo |
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| Cohort 5 (high-fat fed condition) | Experimental | 10 mg BPN-14967 or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPN-14967 | Drug | BPN-14967 oral capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration [AUC(0-t)] | Up to Day 8 | |
| Area under the plasma concentration versus time curve from time 0 extrapolated to infinity [AUC(0-inf)] | Up to Day 8 | |
| Maximum observed plasma concentration (Cmax) | Up to Day 8 | |
| Time to maximum observed plasma concentration (Tmax) | Up to Day 8 | |
| Terminal elimination rate constant | Up to Day 8 | |
| Terminal phase half-life (t1/2) | Up to Day 8 | |
| Apparent total body clearance (CL/F) | Up to Day 8 | |
| Apparent volume of distribution (Vz/F) | Up to Day 8 | |
| Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation | Up to Day 10 | |
| Number of participants with Clinical Laboratory Results Abnormalities | Up to Day 10 | |
| Number of participants with Vital Sign Abnormalities |
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Inclusion Criteria:
Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Konstantin Petrukhin, PhD | Professor of Ophthalmic Science, Department of Ophthalmology, Columbia University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | United States |
After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.
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| Placebo | Drug | Oral capsules |
|
| Up to Day 10 |
| Number of participants with Physical Examination Abnormalities | Up to Day 10 |
| Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities | Up to Day 10 |
| Number of participants with changes in visual acuity | Baseline and Day 10 |
| Number of participants with Ocular Examination Abnormalities | Up to Day 10 |
| Number of participants with changes in color vision | Baseline and Day 10 |