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

Primary Purpose

Early Puberty

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CKD-841 A-1 3.75mg

CKD-841 A-1 1.88mg

CKD-841 D 2.92mg

Leuplin Inj. 3.75 mg

About this trial

This is an interventional treatment trial for Early Puberty focused on measuring CKD-841, Postmenopausal, Leuplin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

CKD-841 A-1(=leuprorelin acetate 3.75mg)

CKD-841 A-1(=leuprorelin acetate 1.88mg)

CKD-841 D(=leuprorelin acetate 2.92mg)

Leuplin Inj.(=leuprorelin acetate 3.75mg)

Arm Description

Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Outcomes

Primary Outcome Measures

PK(Cmax)

Cmax(Maximum concentration of drug in plasma) of Leuprorelin

PK(AUClast)

AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin

PK(AUCinf)

AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin

PK(AUC7-t)

AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin

PK(CL/F)

CL/F(Apparent Clearance) of Leuprorelin

PK(Vd/F)

Vd/F(Apparent Volume of Distribution) of Leuprorelin

PK(Tmax)

Tmax(Time to Cmax/Time to Emax) of Leuprorelin

PK(t1/2)

t1/2(Terminal elimination half-life) of Leuprorelin

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Safety Assessment by evaluating adverse events(AEs).

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

Full Information

NCT ID

NCT04840745

First Posted

April 8, 2021

Last Updated

April 13, 2021

Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04840745

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 2021 (Anticipated)

Primary Completion Date

October 2021 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Puberty

Keywords

CKD-841, Postmenopausal, Leuplin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CKD-841 A-1(=leuprorelin acetate 3.75mg)

Arm Type

Experimental

Arm Description

Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Arm Title

CKD-841 A-1(=leuprorelin acetate 1.88mg)

Arm Type

Experimental

Arm Description

Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Arm Title

CKD-841 D(=leuprorelin acetate 2.92mg)

Arm Type

Experimental

Arm Description

Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Arm Title

Leuplin Inj.(=leuprorelin acetate 3.75mg)

Arm Type

Active Comparator

Arm Description

Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Intervention Type

Drug

Intervention Name(s)

CKD-841 A-1 3.75mg

Other Intervention Name(s)

CKD-841

Intervention Description

Single injection, subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

CKD-841 A-1 1.88mg

Other Intervention Name(s)

CKD-841

Intervention Description

Single injection, subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

CKD-841 D 2.92mg

Other Intervention Name(s)

CKD-841

Intervention Description

Single injection, subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Leuplin Inj. 3.75 mg

Other Intervention Name(s)

Leuplin.Inj

Intervention Description

Single injection, subcutaneous injection

Primary Outcome Measure Information:

Title

PK(Cmax)

Description

Cmax(Maximum concentration of drug in plasma) of Leuprorelin

Time Frame