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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CKD-510 capsule (reference); Drug: CKD-510 tablet (test); Drug: CKD-510 tablet (test)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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); Single-dose of CKD-510 will be administered as oral capsule in a fasted state.; Drug: CKD-510 tablet (test); Single-dose of CKD-510 will be administered as oral tablet in a fasted state.; Drug: CKD-510 tablet (test); Single-dose of CKD-510 will be administered as oral tablet in a fed state.
Experimental: Group 2; 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); Single-dose of CKD-510 will be administered as oral capsule in a fasted state.; Drug: CKD-510 tablet (test); Single-dose of CKD-510 will be administered as oral tablet in a fasted state.; Drug: CKD-510 tablet (test); Single-dose of CKD-510 will be administered as oral tablet in a fed state.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A96_03PK2212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No