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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CKD-510 capsule (reference); Drug: CKD-510 tablet (test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05526742

A96_03PK2212

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Drug: CKD-510 tablet (test)

Drug: CKD-510 tablet (test)

Drug: CKD-510 capsule (reference)

Group 2

Experimental group

Description:

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.

Treatment:

Drug: CKD-510 tablet (test)

Drug: CKD-510 tablet (test)

Drug: CKD-510 capsule (reference)