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Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-510 capsule (reference)

Drug

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

CKD-510 tablet (test)

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2022
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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