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The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840745
Recruitment Status : Not yet recruiting
First Posted : April 12, 2021
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Study Description
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Brief Summary:
A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female

Condition or disease Intervention/treatment Phase
Early Puberty Drug: CKD-841 A-1 3.75mg Drug: CKD-841 A-1 1.88mg Drug: CKD-841 D 2.92mg Drug: Leuplin Inj. 3.75 mg Phase 1

Detailed Description:
To investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. 3.75 mg after subcutaneous injection in postmenopausal female
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Single-blinded, Parallel Design Phase I Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. After Subcutaneous Injection in Postmenopausal Female
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: CKD-841 A-1(=leuprorelin acetate 3.75mg)
Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
 Drug: CKD-841 A-1 3.75mg
Single injection, subcutaneous injection
Other Name: CKD-841
Experimental: CKD-841 A-1(=leuprorelin acetate 1.88mg)
Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
 Drug: CKD-841 A-1 1.88mg
Single injection, subcutaneous injection
Other Name: CKD-841
Experimental: CKD-841 D(=leuprorelin acetate 2.92mg)
Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
 Drug: CKD-841 D 2.92mg
Single injection, subcutaneous injection
Other Name: CKD-841
Active Comparator: Leuplin Inj.(=leuprorelin acetate 3.75mg)
Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
 Drug: Leuplin Inj. 3.75 mg
Single injection, subcutaneous injection
Other Name: Leuplin.Inj


Outcome Measures
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Primary Outcome Measures :
  1. PK(Cmax) [ Time Frame: From before injection to up to 1008 hours post injection ]
    Cmax(Maximum concentration of drug in plasma) of Leuprorelin

  2. PK(AUClast) [ Time Frame: From before injection to up to 1008 hours post injection ]
    AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin

  3. PK(AUCinf) [ Time Frame: From before injection to up to 1008 hours post injection ]
    AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin

  4. PK(AUC7-t) [ Time Frame: From before injection to up to 1008 hours post injection ]
    AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin

  5. PK(CL/F) [ Time Frame: From before injection to up to 1008 hours post injection ]
    CL/F(Apparent Clearance) of Leuprorelin

  6. PK(Vd/F) [ Time Frame: From before injection to up to 1008 hours post injection ]
    Vd/F(Apparent Volume of Distribution) of Leuprorelin

  7. PK(Tmax) [ Time Frame: From before injection to up to 1008 hours post injection ]
    Tmax(Time to Cmax/Time to Emax) of Leuprorelin

  8. PK(t1/2) [ Time Frame: From before injection to up to 1008 hours post injection ]
    t1/2(Terminal elimination half-life) of Leuprorelin

  9. PD(AUEC0-42d below baseline) [ Time Frame: From before injection to up to 1008 hours post injection ]
    AUEC0-42d below baseline((AUEC that is below the baseline from 0 h to 42 days)) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.

  10. PD(AUEC0-28d below baseline) [ Time Frame: From before injection to up to 1008 hours post injection ]
    AUEC0-28d below baseline(AUEC that is below the baseline from 0 h to 28 days) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.

  11. PD(Area under the response (% change from baseline) curve) [ Time Frame: From before injection to up to 1008 hours post injection ]
    AUEC(Area under the response (% change from baseline) curve) above baseline of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.

  12. PD(Tmax) [ Time Frame: From before injection to up to 1008 hours post injection ]
    Tmax(Time to Cmax/Time to Emax) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.

  13. PD(Tmin) [ Time Frame: From before injection to up to 1008 hours post injection ]
    Tmin(Time to Emin) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.

  14. PD(Emax) [ Time Frame: From before injection to up to 1008 hours post injection ]
    Emax(Maximum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.

  15. PD(Emin) [ Time Frame: From before injection to up to 1008 hours post injection ]
    Emin(Minimum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.


Secondary Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 < 28.0

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 in the last three months
  • 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
Contacts and Locations
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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): NCT04840745


Contacts
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Contact: Min Soo Park, Ph.D 82-2-2228-0401 minspark@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, Korea, Republic of, 03722
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Severance Hospital
Investigators
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Principal Investigator: Min Soo Park, Ph.D Severance Hospital
More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT04840745    
Other Study ID Numbers: A55_03PK2023
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-841
Postmenopausal
Leuplin
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Leuprolide
Fertility Agents, Female
 Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents