Clinical trial NCT05526742: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Cmax after administration of either capsule or tablet formulation in fasted state
timeFrame: From Day 1 to Day 3 of each Treatment Period
measure: Plasma AUC after administration of either capsule or tablet formulation in fasted state
timeFrame: From Day 1 to Day 3 of each Treatment Period
measure: Plasma Tmax after administration of either capsule or tablet formulation in fasted state
timeFrame: From Day 1 to Day 3 of each Treatment Period
measure: Plasma T1/2 after administration of either capsule or tablet formulation in fasted state: T1/2
timeFrame: From Day 1 to Day 3 of each Treatment Period
measure: Plasma Cmax after administration of tablet formulation in the fed and fasted states
timeFrame: From Day 1 to Day 3 of each Treatment Period
measure: Plasma AUC after administration of tablet formulation in the fed and fasted states
timeFrame: From Day 1 to Day 3 of each Treatment Period
measure: Plasma Tmax after administration of tablet formulation in the fed and fasted states
timeFrame: From Day 1 to Day 3 of each Treatment Period
measure: Plasma T1/2 after administration of tablet formulation in the fed and fasted states
timeFrame: From Day 1 to Day 3 of each Treatment Period
measure: Safety and tolerability including treatment-emergent AE and treatment-emergent SAE
timeFrame: From Day 1 to Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Clinical Pharmacology Unit
state: Ohio
Study officials:
References: