CKD-841 Pharmacokinetic/Pharmacodynamic Study

Postmenopausal Disorder Clinical Trial

Official title:

Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233932
• Other study ID #: 155HPS14022
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2016
• Last updated: July 26, 2017
• Start date: April 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female.

Description:

To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj. 3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

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 < 25

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

• 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

• Has abnormal function of liver and kidney at screening

Related Conditions & MeSH terms

• Postmenopausal Disorder

Intervention

Drug:
• Leuplin?Inj
Investigational drug(=Leuplin?Inj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
• CKD-841
Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.

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	Peak Plasma Concentration (Cmax) of Leuprorelin	Peak Plasma Concentration (Cmax) in ng/mL	From before injection to up to 1008 hours post injection
Primary	Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin	Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL	From before injection to up to 1008 hours post injection
Primary	Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin	Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL	From before injection to up to 1008 hours post injection
Primary	Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin	Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL	From before injection to up to 1008 hours post injection
Primary	The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin	The time -to-maximal serum or plasma concentrations (Tmax) in hr	From before injection to up to 1008 hours post injection
Primary	Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin	Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L	From before injection to up to 1008 hours post injection
Primary	Follicular Stimulating Hormone(FSH) of Leuprorelin	Follicular Stimulating Hormone(FSH) in IU/L	From before injection to up to 1008 hours post injection
Primary	Estradiol of Leuprorelin	Estradiol in pg/ml	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