A Study to Evaluate the Relative Bioavailability of Formulations of CKD-510 and to Assess the Effect of Food on the CKD-510 Tablet Formulation in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine the relative bioavailability of CKD-510 tablet formulation compared with CKD-510 capsule formulation, and to characterize the effect of food on the CKD-510 tablet.

Official Title
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A Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of a Tablet Formulation of CKD-510 as Compared to Capsule and to Assess the Effect of Food on the CKD 510 Tablet Formulation in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CKD-510 capsule (reference)
* Drug: CKD-510 tablet (test)
* Drug: CKD-510 tablet (test)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male or female subject between 18 and 60 years of age In generally good health, based upon medical/surgical history and the results of physical examination, vital signs, safety laboratory assessments, and 12-lead ECG Body mass index (BMI) between 18 and 32 kg/m2 If a female subject of childbearing potential, agrees to use a highly effective method of contraception during study participation and for 90 days after the last administration of study drug. If a male subject with a female partner of childbearing potential, is surgically sterile or agrees to use a highly effective method of contraception during study participation and for 90 days after the last administration of study drug Negative test result for SARS-CoV-2 Exclusion Criteria: Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, or allergic disease or any other condition Any hypersensitivity or allergy to CKD-510 or its excipients or to any medicinal products with similar chemical structures History of malignancy, other than successfully treated basal cell or squamous cell skin cancer History or presence of an abnormal 12-lead ECG Acute illness considered clinically significant by the Investigator within 30 days prior to Randomization Any other investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Randomization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Subjects will receive single-dose of CKD-510 capsule in fasted state (treatment A) on Day 1 of Period 1 and tablet in fasted state (treatment B) on Day 1 of Period 2, and then receive tablet in a fed state (treatment C) on Day 1 of Period 3. A washout period will be at least 7 days between each treatment period. | Drug: CKD-510 capsule (reference)<br>* Single-dose of CKD-510 will be administered as oral capsule in a fasted state.<br>Drug: CKD-510 tablet (test)<br>* Single-dose of CKD-510 will be administered as oral tablet in a fasted state.<br>Drug: CKD-510 tablet (test)<br>* Single-dose of CKD-510 will be administered as oral tablet in a fed state.<br>|
| Experimental: Group 2<br>Subjects will receive single-dose of CKD-510 tablet in a fed state (treatment C) on Day 1 of Period 1 and tablet in fasted state (treatment B) on Day 1 of Period 2, and then receive capsule in fasted state (treatment A) on Day 1 of Period 3. A washout period will be at least 7 days between each treatment period. | Drug: CKD-510 capsule (reference)<br>* Single-dose of CKD-510 will be administered as oral capsule in a fasted state.<br>Drug: CKD-510 tablet (test)<br>* Single-dose of CKD-510 will be administered as oral tablet in a fasted state.<br>Drug: CKD-510 tablet (test)<br>* Single-dose of CKD-510 will be administered as oral tablet in a fed state.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Cmax after administration of either capsule or tablet formulation in fasted state | Maximum plasma concentration (Cmax) | From Day 1 to Day 3 of each Treatment Period | 
| Plasma AUC after administration of either capsule or tablet formulation in fasted state | Area under the concentration-time curve (AUC) | From Day 1 to Day 3 of each Treatment Period | 
| Plasma Tmax after administration of either capsule or tablet formulation in fasted state | Time to maximum plasma concentration (Tmax) | From Day 1 to Day 3 of each Treatment Period | 
| Plasma T1/2 after administration of either capsule or tablet formulation in fasted state: T1/2 | Terminal phase elimination half-life (T1/2) | From Day 1 to Day 3 of each Treatment Period | 
| Plasma Cmax after administration of tablet formulation in the fed and fasted states | Maximum plasma concentration (Cmax) | From Day 1 to Day 3 of each Treatment Period | 
| Plasma AUC after administration of tablet formulation in the fed and fasted states | Area under the concentration-time curve (AUC) | From Day 1 to Day 3 of each Treatment Period | 
| Plasma Tmax after administration of tablet formulation in the fed and fasted states | Time to maximum plasma concentration (Tmax) | From Day 1 to Day 3 of each Treatment Period | 
| Plasma T1/2 after administration of tablet formulation in the fed and fasted states | Terminal phase elimination half-life (T1/2) | From Day 1 to Day 3 of each Treatment Period | 
| Safety and tolerability including treatment-emergent AE and treatment-emergent SAE |  | From Day 1 to Day 7 |