Postmenopausal DisorderPhase 1NCT03233932
CKD-841 Pharmacokinetic/Pharmacodynamic Study
A Phase 1 study testing LeuplinⓡInj and CKD-841 in people with Postmenopausal Disorder, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Postmenopausal Disorder
- What is being tested?
- LeuplinⓡInj and CKD-841
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, 03722
About this study
Official title: 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.
Read the 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.
- Conditions
- Postmenopausal Disorder
- Being tested
- LeuplinⓡInj, CKD-841
- Keywords
- CKD-841, Leuplin, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuplinⓡInjDrug
Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
CKD-841Drug
Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
| Study group | Role | What they receive |
|---|---|---|
| LeuplinⓡInj | Active comparator | LeuplinⓡInj(=leuprorelin acetate 3.75mg) Receives: Drug: LeuplinⓡInj |
| CKD-841 | Experimental | CKD-841(=leuprorelin acetate 3.75mg) Receives: Drug: CKD-841 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of Leuprorelin
Peak Plasma Concentration (Cmax) in ng/mL
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From before injection to up to 1008 hours post injection
Follicular Stimulating Hormone(FSH) of Leuprorelin
Follicular Stimulating Hormone(FSH) in IU/L
Measured: From before injection to up to 1008 hours post injection
Estradiol of Leuprorelin
Estradiol in pg/ml
Measured: From before injection to up to 1008 hours post injection
Secondary outcomes (1)
Safety Assessment by evaluating adverse events(AEs).
Assessment of the safety of subjects by evaluating adverse events(AEs).
Measured: From day1 to day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study startApr 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233932
- Sponsor's protocol ID
- 155HPS14022
- Status last verified
- Jul 2017
- First submitted
- 23 May 2016
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female
- ClinicalTrials.gov ID
- NCT03233932
- Acronym / sponsor ID
- 155HPS14022
- Conditions
- Postmenopausal Disorder
- Keywords
- CKD-841, Leuplin, Postmenopausal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LeuplinⓡInj | Active comparator | Drug: LeuplinⓡInjLeuplinⓡInj(=leuprorelin acetate 3.75mg) |
| CKD-841 | Experimental | Drug: CKD-841CKD-841(=leuprorelin acetate 3.75mg) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeuplinⓡInjInvestigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once. | Drug | LeuplinⓡInj |
| CKD-841Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once. | Drug | CKD-841 |
Primary outcome
Peak Plasma Concentration (Cmax) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Peak Plasma Concentration (Cmax) in ng/mL
Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL
Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL
Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin
Time frame: 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) in ng•hr/mL
The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
The time -to-maximal serum or plasma concentrations (Tmax) in hr
Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L
Follicular Stimulating Hormone(FSH) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Follicular Stimulating Hormone(FSH) in IU/L
Estradiol of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Estradiol in pg/ml
1 secondary outcome
Safety Assessment by evaluating adverse events(AEs).
Time frame: From day1 to day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Soo Park, Ph.D principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LeuplinⓡInj and CKD-841 in people with Postmenopausal Disorder, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of Leuprorelin (time frame: From before injection to up to 1008 hours post injection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.