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

NCT04840745 | Unknown Phase 1

• 1 other identifier: A55_03PK2023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Early Puberty

Keywords

CKD-841; Postmenopausal; Leuplin

Outcome Measures

Primary Outcomes (15)

• PK(Cmax)

  Cmax(Maximum concentration of drug in plasma) of Leuprorelin

  From before injection to up to 1008 hours post injection

• 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

• 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

• 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

• PK(CL/F)

  CL/F(Apparent Clearance) of Leuprorelin

  From before injection to up to 1008 hours post injection

• PK(Vd/F)

  Vd/F(Apparent Volume of Distribution) of Leuprorelin

  From before injection to up to 1008 hours post injection

• PK(Tmax)

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

  From before injection to up to 1008 hours post injection

• PK(t1/2)

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

  From before injection to up to 1008 hours post injection

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Safety Assessment by evaluating adverse events(AEs).

  From day1 to day 56

Study Arms (4)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

CKD-841 D(=leuprorelin acetate 2.92mg)

EXPERIMENTAL

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

Drug: CKD-841 D 2.92mg

Leuplin Inj.(=leuprorelin acetate 3.75mg)

ACTIVE COMPARATOR

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

Drug: Leuplin Inj. 3.75 mg

Interventions

CKD-841 A-1 3.75mg DRUG

Single injection, subcutaneous injection

Also known as: CKD-841

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

CKD-841 A-1 1.88mg DRUG

Single injection, subcutaneous injection

Also known as: CKD-841

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

CKD-841 D 2.92mg DRUG

Single injection, subcutaneous injection

Also known as: CKD-841

CKD-841 D(=leuprorelin acetate 2.92mg)

Leuplin Inj. 3.75 mg DRUG

Single injection, subcutaneous injection

Also known as: Leuplin.Inj

Leuplin Inj.(=leuprorelin acetate 3.75mg)

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Severance Hospital: collaborator

Study Sites (1)

Severance Hospital

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

Location

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Min Soo Park, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Soo Park, Ph.D

CONTACT

82-2-2228-0401; minspark@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: April 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)