The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1
- Conditions
- Early Puberty
- Interventions
- Registration Number
- NCT04840745
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKD-841 A-1(=leuprorelin acetate 1.88mg) CKD-841 A-1 1.88mg Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. CKD-841 D(=leuprorelin acetate 2.92mg) CKD-841 D 2.92mg Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. CKD-841 A-1(=leuprorelin acetate 3.75mg) CKD-841 A-1 3.75mg Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. Leuplin Inj.(=leuprorelin acetate 3.75mg) Leuplin Inj. 3.75 mg Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Safety Assessment by evaluating adverse events(AEs). From day1 to day 56 Assessment of the safety of subjects by evaluating adverse events(AEs).
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Yonsei-ro, Seodaemun-gu 50-1, Korea, Republic of