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Completed

NCT Number: NCT03233932

CKD-841 Pharmacokinetic/Pharmacodynamic Study

A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female.

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Key information

Conditions

Postmenopausal Disorder

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, Yonsei-ro, Seodaemun-gu 50-1, 03722, South Korea

About this study

To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj. 3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy menopausal female
  • β-hCG is negative at screening and before administration of investigational drug
  • Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc...
  • Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and < 25

Exclusion criteria

  • History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease
  • Uncontrolled diabetes mellitus
  • Pregnancy or breast feeding
  • History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug
  • Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially
  • Has abnormal function of liver and kidney at screening

Treatment and study plan

LeuplinⓡInj

Drug

Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.

CKD-841

Drug

Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of Leuprorelin

    Time frame: From before injection to up to 1008 hours post injection

    Peak Plasma Concentration (Cmax) in ng/mL

  2. Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin

    Time frame: From before injection to up to 1008 hours post injection

    Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL

  3. Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin

    Time frame: From before injection to up to 1008 hours post injection

    Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL

  4. Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin

    Time frame: From before injection to up to 1008 hours post injection

    Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL

  5. The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin

    Time frame: From before injection to up to 1008 hours post injection

    The time -to-maximal serum or plasma concentrations (Tmax) in hr

  6. Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin

    Time frame: From before injection to up to 1008 hours post injection

    Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L

  7. Follicular Stimulating Hormone(FSH) of Leuprorelin

    Time frame: From before injection to up to 1008 hours post injection

    Follicular Stimulating Hormone(FSH) in IU/L

  8. Estradiol of Leuprorelin

    Time frame: From before injection to up to 1008 hours post injection

    Estradiol in pg/ml

Secondary outcomes

  1. Safety Assessment by evaluating adverse events(AEs).

    Time frame: From day1 to day 56

    Assessment of the safety of subjects by evaluating adverse events(AEs).

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Collaborators

  • Severance Hospital

Registry information

Official study title

Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2017
Registry last updated
Jul 31, 2017

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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