AnemiaPhase 1NCT01685671
Pharmacokinetics Study of CKD-11101 and NESP After SC Administration in Health Male Volunteers
A Phase 1 study testing NESP 60μg and CKD-11101 60μg in people with Anemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC administration in health male volunteers Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- NESP 60μg and CKD-11101 60μg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2012to 15 Jan 2013
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed the informed consent form prior to study participation.
- A healthy male volunteer between 20 and 55 years old.
- Body weight between 55kg and 90kg, BMI between 18 and 27.
- Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)
Who cannot join
- Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases
- Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor
- Have abnormal laboratory result.
- Hemoglobin < 12g/dL or > 17g/dL
- Vitamin B12 < 200pg/mL
- Ferritin < 21.8ng/mL
Show all 25Show fewer
- Transferrin < 190mg/dL
- Reticulocyte over the normal limit
- Positive for the Triage TOX drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)
- Positive for HIV antibody, HBsAg, HCV antibody test
- A heavy smoker (cigarette > 10 cigarettes per day)
- Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration
- Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron tablets
- sit SBP < 90mmHg or sit SBP > 140mmHg or sit DBP < 55mmHg or sit DBP > 90mmHg or Pulse rate > 100 per/min
- History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening
- Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days before the first IP administration
- Participated in the other clinical trials and administrated IP within 8 weeks prior to the first IP administration
- A heavy alcohol consumer (alcohol > 21 units/week) or cannot stop drinking
- Bleed or donate blood (> 400mL) within 8 weeks before the first IP administration
- Participated in this clinical trials and administrated IP
- Have a diet within 2 days before the first IP administration or cannot stop having
- food containing grapefruit
- food containing caffeine
- Disagree to avoid getting pregnant during clinical trial
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After SC Administration in Health Male Volunteers
The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC administration in health male volunteers
Read the detailed description
Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.
- Conditions
- Anemia
- Being tested
- NESP 60μg, CKD-11101 60μg
- Keywords
- CKD-11101, NESP, Darbepoetin alfa, Anemia, subcutaneous, Pharmacokinetics, Phase 1
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NESP 60μgDrug
Administrated NESP 60μg once subcutaneously
CKD-11101 60μgDrug
Administrated CKD-11101 60μg once subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| NESP 60μg | Active comparator | Prefilled syringe filled with Darbepoetin alfa 60μg Receives: Drug: NESP 60μg |
| CKD-11101 60μg | Experimental | Prefilled syringe filled with Darbepoetin alfa 60μg Receives: Drug: CKD-11101 60μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess AUClast of darbepoetin alfa
Measured: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess Cmax of darbepoetin alfa
Measured: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Secondary outcomes (4)
Assess AUCinf of darbepoetin alfa
Measured: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess Tmax of darbepoetin alfa
Measured: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess t1/2 of darbepoetin alfa
Measured: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess CL of darbepoetin alfa
Measured: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study start26 Oct 2012
- Primary completion25 Dec 2012
- Study completion15 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
- Investigators
- Kyung Sang Yu, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685671
- Sponsor's protocol ID
- 136HPS12C
- Status last verified
- May 2017
- First submitted
- 12 Sep 2012
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After SC Administration in Health Male Volunteers
- ClinicalTrials.gov ID
- NCT01685671
- Acronym / sponsor ID
- 136HPS12C
- Conditions
- Anemia
- Keywords
- CKD-11101, NESP, Darbepoetin alfa, Anemia, subcutaneous, Pharmacokinetics, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- 26 Oct 2012 (actual)
- Primary completion
- 25 Dec 2012 (actual)
- Study completion
- 15 Jan 2013 (actual)
- First posted
- 14 Sep 2012 (estimated)
- 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.
The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC administration in health male volunteers
Detailed description
Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NESP 60μg | Active comparator | Drug: NESP 60μgPrefilled syringe filled with Darbepoetin alfa 60μg |
| CKD-11101 60μg | Experimental | Drug: CKD-11101 60μgPrefilled syringe filled with Darbepoetin alfa 60μg |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed the informed consent form prior to study participation.
- A healthy male volunteer between 20 and 55 years old.
- Body weight between 55kg and 90kg, BMI between 18 and 27.
- Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)
Key exclusion criteria (25 listed)
- Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases
- Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor
- Have abnormal laboratory result.
- A heavy smoker (cigarette > 10 cigarettes per day)
- Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration
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 |
|---|---|---|
| NESP 60μgAdministrated NESP 60μg once subcutaneously | Drug | NESP 60μg |
| CKD-11101 60μgAdministrated CKD-11101 60μg once subcutaneously | Drug | CKD-11101 60μg |
Primary outcome
Assess AUClast of darbepoetin alfa
Time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess Cmax of darbepoetin alfa
Time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
4 secondary outcomes
Assess AUCinf of darbepoetin alfa
Time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess Tmax of darbepoetin alfa
Time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess t1/2 of darbepoetin alfa
Time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess CL of darbepoetin alfa
Time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
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 23 May 2017.
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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.
Kyung Sang Yu, Ph.D principal investigator
Seoul National University 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 NESP 60μg and CKD-11101 60μg in people with Anemia, 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 25 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 23 May 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?
Assess AUClast of darbepoetin alfa (time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h). The study lists 2 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 23 May 2017.