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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CKD-510 capsule (reference); Drug: CKD-510 tablet (test)

• Registration Number: NCT05526742
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-24
• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-02
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	CKD-510 capsule (reference)	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.
Group 2	CKD-510 tablet (test)	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.
Group 1	CKD-510 capsule (reference)	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.
Group 1	CKD-510 tablet (test)	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇺🇸 Cincinnati, Ohio, United States