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This study will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions.
This is an open-label, single-dose, randomized, two-treatment, two-period, two-sequence crossover relative bioavailability study under fasted and fed conditions. It will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions. The screening period will be up to 28 days. Patients that are eligible will enter the clinical facility at least 10.5 hours prior to dosing. Depending on their randomization patients will be fed or fasted prior to dosing. They will remain confined for at least 24 hours. After leaving confinement, patients will return to the clinic 9 times for blood draws. At least 56 days after the first dosing, patients will return to the clinic and go through the same process. Those previously fed before dosing will be fasted and those previously fasted will be fed. Patients will return 9 times after their second confinement for additional blood draws.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDC Tablet Fed + Fast | Experimental | Participants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fed condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Table in a fasted condition after, at a minimum, a 56 day washout. |
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| FDC Tablet Fast + Fed | Experimental | Participants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fasted condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Table in a fed condition after, at a minimum, a 56 day washout. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed-Dose Combination (FDC) Tablet | Drug | Obicetrapib/Ezetimibe FDC tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum measured plasma concentration following each treatment. | 528.00 hours |
| AUC0-t | Area under the plasma concentration versus time curve from time zero to the time of the last measurable plasma concentration, as calculated by linear trapezoidal method. | 528.00 hours |
| AUC0-∞ | Area under the plasma concentration versus time curve from time zero to infinity where AUC0-∞ = AUC0-t + Ct/λz. Ct is the last measurable concentration and λz is the terminal rate constant. | 528.00 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value. | 528.00 hours |
| Tlag | Time delay in achieving Tmax |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOVUM | Las Vegas | Nevada | 89121 | United States |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Open-Label, Single-Dose, Randomized, Two-Treatment, Two-Period, Two-Sequence, Crossover Study
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| 528.00 hours |
| λz | First order rate constant associated with the terminal (log-linear) portion of the curve. | 528.00 hours |
| t½ | The terminal half-life will be calculated as ln(2)/λz. | 528.00 hours |
| CL/F | Apparent oral systemic clearance, calculated as Dose/AUC0-∞ | 528.00 hours |
| Vd/F | Apparent volume of distribution during terminal phase, calculated as Dose/(AUC0-∞ × λz) | 528.00 hours |
| R2 adjusted | Goodness of fit statistic for the terminal phase, adjusted for the number of points used in the estimation of λz. | 528.00 hours |
| AUC_%Extrap_obs | The residual area in percentage will be determined by the formula, [(AUC0-∞-AUC0-t)/AUC0-∞] × 100. | 528.00 hours |