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

Early Puberty Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04840745
• Other study ID #: A55_03PK2023
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2021
• Est. completion date: November 2021

Study information

• Verified date: April 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: Min Soo Park, Ph.D
• Phone: 82-2-2228-0401
• Email: minspark[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: November 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Healthy menopausal female

• ß-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

Related Conditions & MeSH terms

• Early Puberty
• Puberty, Precocious

Intervention

Drug:
• CKD-841 A-1 3.75mg
Single injection, subcutaneous injection
• CKD-841 A-1 1.88mg
Single injection, subcutaneous injection
• CKD-841 D 2.92mg
Single injection, subcutaneous injection
• Leuplin Inj. 3.75 mg
Single injection, subcutaneous injection

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Yonsei-ro, Seodaemun-gu 50-1

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK(Cmax)	Cmax(Maximum concentration of drug in plasma) of Leuprorelin	From before injection to up to 1008 hours post injection
Primary	PK(AUClast)	AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin	From before injection to up to 1008 hours post injection
Primary	PK(AUCinf)	AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin	From before injection to up to 1008 hours post injection
Primary	PK(AUC7-t)	AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin	From before injection to up to 1008 hours post injection
Primary	PK(CL/F)	CL/F(Apparent Clearance) of Leuprorelin	From before injection to up to 1008 hours post injection
Primary	PK(Vd/F)	Vd/F(Apparent Volume of Distribution) of Leuprorelin	From before injection to up to 1008 hours post injection
Primary	PK(Tmax)	Tmax(Time to Cmax/Time to Emax) of Leuprorelin	From before injection to up to 1008 hours post injection
Primary	PK(t1/2)	t1/2(Terminal elimination half-life) of Leuprorelin	From before injection to up to 1008 hours post injection
Primary	PD(AUEC0-42d below baseline)	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.	From before injection to up to 1008 hours post injection
Primary	PD(AUEC0-28d below baseline)	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.	From before injection to up to 1008 hours post injection
Primary	PD(Area under the response (% change from baseline) curve)	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.	From before injection to up to 1008 hours post injection
Primary	PD(Tmax)	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.	From before injection to up to 1008 hours post injection
Primary	PD(Tmin)	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.	From before injection to up to 1008 hours post injection
Primary	PD(Emax)	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.	From before injection to up to 1008 hours post injection
Primary	PD(Emin)	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.	From before injection to up to 1008 hours post injection
Secondary	Safety Assessment by evaluating adverse events(AEs).	Assessment of the safety of subjects by evaluating adverse events(AEs).	From day1 to day 56