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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

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ClinicalTrials.gov Identifier: NCT05526742
Recruitment Status : Recruiting
First Posted : September 2, 2022
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: CKD-510 capsule (reference) Drug: CKD-510 tablet (test) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 24, 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

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.




Primary Outcome Measures :
  1. Plasma Cmax after administration of either capsule or tablet formulation in fasted state [ Time Frame: From Day 1 to Day 3 of each Treatment Period ]
    Maximum plasma concentration (Cmax)

  2. Plasma AUC after administration of either capsule or tablet formulation in fasted state [ Time Frame: From Day 1 to Day 3 of each Treatment Period ]
    Area under the concentration-time curve (AUC)

  3. Plasma Tmax after administration of either capsule or tablet formulation in fasted state [ Time Frame: From Day 1 to Day 3 of each Treatment Period ]
    Time to maximum plasma concentration (Tmax)

  4. Plasma T1/2 after administration of either capsule or tablet formulation in fasted state: T1/2 [ Time Frame: From Day 1 to Day 3 of each Treatment Period ]
    Terminal phase elimination half-life (T1/2)

  5. Plasma Cmax after administration of tablet formulation in the fed and fasted states [ Time Frame: From Day 1 to Day 3 of each Treatment Period ]
    Maximum plasma concentration (Cmax)

  6. Plasma AUC after administration of tablet formulation in the fed and fasted states [ Time Frame: From Day 1 to Day 3 of each Treatment Period ]
    Area under the concentration-time curve (AUC)

  7. Plasma Tmax after administration of tablet formulation in the fed and fasted states [ Time Frame: From Day 1 to Day 3 of each Treatment Period ]
    Time to maximum plasma concentration (Tmax)

  8. Plasma T1/2 after administration of tablet formulation in the fed and fasted states [ Time Frame: From Day 1 to Day 3 of each Treatment Period ]
    Terminal phase elimination half-life (T1/2)

  9. Safety and tolerability including treatment-emergent AE and treatment-emergent SAE [ Time Frame: From Day 1 to Day 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05526742


Locations
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United States, Ohio
Clinical Pharmacology Unit Recruiting
Cincinnati, Ohio, United States, 45227
Contact: M. Dawn Browning    513-366-3220    m.browning@.com   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT05526742    
Other Study ID Numbers: A96_03PK2212
First Posted: September 2, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No