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

NCT05526742 | Completed Phase 1 FDA Drug

• 1 other identifier: A96_03PK2212
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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); Drug: CKD-510 tablet (test)

Group 2

EXPERIMENTAL

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); Drug: CKD-510 tablet (test)

Interventions

CKD-510 capsule (reference) DRUG

Single-dose of CKD-510 will be administered as oral capsule in a fasted state.

Group 1; Group 2

CKD-510 tablet (test) DRUG

Single-dose of CKD-510 will be administered as oral tablet in a fasted state.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: August 24, 2022
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

US (1)