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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05526742
• Other study ID #: A96_03PK2212
• Status: Completed
• Phase: Phase 1
• Start date: August 24, 2022
• Est. completion date: September 13, 2022

Study information

• Verified date: March 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CKD-510 capsule (reference)
Single-dose of CKD-510 will be administered as oral capsule in a fasted state.
• CKD-510 tablet (test)
Single-dose of CKD-510 will be administered as oral tablet in a fasted state.
• CKD-510 tablet (test)
Single-dose of CKD-510 will be administered as oral tablet in a fed state.

Locations

Country	Name	City	State
United States	Clinical Pharmacology Unit	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Safety and tolerability including treatment-emergent AE and treatment-emergent SAE		From Day 1 to Day 7