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

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04840745

Collaborator

Severance Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: Leuplin.Inj

Outcome Measures

Primary Outcome Measures

PK(Cmax) [From before injection to up to 1008 hours post injection]
Cmax(Maximum concentration of drug in plasma) of Leuprorelin
PK(AUClast) [From before injection to up to 1008 hours post injection]
AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin
PK(AUCinf) [From before injection to up to 1008 hours post injection]
AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin
PK(AUC7-t) [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
PK(CL/F) [From before injection to up to 1008 hours post injection]
CL/F(Apparent Clearance) of Leuprorelin
PK(Vd/F) [From before injection to up to 1008 hours post injection]
Vd/F(Apparent Volume of Distribution) of Leuprorelin
PK(Tmax) [From before injection to up to 1008 hours post injection]
Tmax(Time to Cmax/Time to Emax) of Leuprorelin
PK(t1/2) [From before injection to up to 1008 hours post injection]
t1/2(Terminal elimination half-life) of Leuprorelin
PD(AUEC0-42d below baseline) [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.
PD(AUEC0-28d below baseline) [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.
PD(Area under the response (% change from baseline) curve) [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.
PD(Tmax) [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.
PD(Tmin) [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.
PD(Emax) [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.
PD(Emin) [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

Safety Assessment by evaluating adverse events(AEs). [From day1 to day 56]
Assessment of the safety of subjects by evaluating adverse events(AEs).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul	Yonsei-ro, Seodaemun-gu 50-1	Korea, Republic of	03722

Sponsors and Collaborators

Chong Kun Dang Pharmaceutical
Severance Hospital

Investigators

Principal Investigator: Min Soo Park, Ph.D, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chong Kun Dang Pharmaceutical

ClinicalTrials.gov Identifier:

NCT04840745

Other Study ID Numbers:

A55_03PK2023

First Posted:

Apr 12, 2021

Last Update Posted:

Apr 19, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chong Kun Dang Pharmaceutical

CKD-841

Postmenopausal

Leuplin

Additional relevant MeSH terms:

Puberty, Precocious

Leuprolide

Study Results

No Results Posted as of Apr 19, 2021