CKD-841 Pharmacokinetic/Pharmacodynamic Study

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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Disorder
• Intervention / Treatment: Drug: LeuplinⓡInj; Drug: CKD-841

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yonsei-ro, Seodaemun-gu 50-1
    • Seoul, Yonsei-ro, Seodaemun-gu 50-1, Korea, Republic of, 03722
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 < 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LeuplinⓡInj; LeuplinⓡInj(=leuprorelin acetate 3.75mg)	Drug: LeuplinⓡInj; Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
Experimental: CKD-841; CKD-841(=leuprorelin acetate 3.75mg)	Drug: CKD-841; Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax) of Leuprorelin	Peak Plasma Concentration (Cmax) in ng/mL	From before injection to up to 1008 hours post injection
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
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
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
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
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
Follicular Stimulating Hormone(FSH) of Leuprorelin	Follicular Stimulating Hormone(FSH) in IU/L	From before injection to up to 1008 hours post injection
Estradiol of Leuprorelin	Estradiol in pg/ml	From before injection to up to 1008 hours post injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment by evaluating adverse events(AEs).	Assessment of the safety of subjects by evaluating adverse events(AEs).	From day1 to day 56

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Postmenopausal; CKD-841; Leuplin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: 155HPS14022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No