Relative BioavailabilityPhase 1NCT03154840
Relative Bioavailability Among Different Eutropin Formulations
A Phase 1 study testing Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU in people with Relative Bioavailability, run by LG Chem at 1 site in South Korea.
Trial summary
1. Compares and evaluates the relative bioavailability of single-dose subcutaneous administration of each of the Eutropin formulations to healthy male volunteers. 2. Ensure safety and tolerability of single, subcutaneous administration of Eutropin formulations to healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Relative Bioavailability
- What is being tested?
- Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2017to 30 Nov 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 19 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy male who is at least 19 years old but under 40 years of age at screening visit
- Those who weigh more than 50 kg at screening visit and whose body mass index (BMI) is greater than 19 kg / m2 but less than 28 kg / m2
- The result of the vital signs in the screening period.
- A person who is judged to be clinically insignificant in terms of physical or mental condition when the examinee medically judges the screening period physical examination
- Those who are not clinically significant when the examiner has medically judged the results of examination other than the items described in 17) and 18) of the exclusion criterion in the diagnosis laboratory test results in the screening period
- A person who consents to use a combination of effective contraceptive methods or medically appropriate contraceptive methods from the first administration of the clinical trial drug to the fourth administration (28 days) after the last administration of the drug for clinical trial and not to provide sperm
- Those who voluntarily decide to participate in clinical trials and observe the test subjects' precautions and agree in writing
Who cannot join
- Those who with a history or history of diabetes
- Those who with a history or history of malignancy
- Those who with a history or history of musculoskeletal disorders (including epiphyseal closure, scoliosis, etc.)
- Those who with history or history of endocrine system (including hypothyroidism, panhypopituitarism, etc.)
- Those who have a history of skin disease, including psoriasis and contact dermatitis, or who can not exclude the possibility of skin disease under the judgment of the examiner on physical examination conducted at the screening visit.
- Exclusion Criteria In addition to items 1) to 5), there are other clinically significant history or history of liver, kidney, digestive system, respiratory system, neuropsychiatry, blood /
Show all 27Show fewer
- Persons with a history of somatropin and octreotide acetate or hypersensitivity reactions to cresol, glycerol or other drugs (non-steroidal anti-inflammatory drugs, antibiotics, etc.)
- Those who have participated in other clinical trials or bioequivalence tests within 90 days of the screening visit date
- Within 60 days before screening visit Those who have received blood (blood, whole blood, etc.) or blood transfusions
- Those who ingest herbal medicines or health functional foods within 14 days before the screening visit or those who are expected to affect the clinical trial within 7 days
- Within 14 days prior to screening visit, special medicines that may affect the clinical trial, or those who use general medicines within 7 days
- Screening Within 30 days prior to the visiting date Alcohol Abuse (alcohol-containing beverage> 21 units / week)
- Over 30 days before screening visit Overcame smoker (cigarette> 10 cigarettes / day)
- Within 7 days of screening visit Caffeine-containing foods Excessive intake (caffeinated foods> 3 times / week)
- Screening Within 7 days prior to the visit Date of intake of food containing xanthine
- As a result of urine nicotine test or urine drug screening test during the screening period
- Screening period serum test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test) Result positive
- Diagnosis of Screening Period In the case of a laboratory test, one or more of the following findings
- Fasting glucose> 110 mg / dL
- TSH Reference Range Above upper limit or below lower limit
- IGF-1 and IGFBP-3 according to the age of the test subjects. Reference range Above upper limit or below lower limit
- Vitamin B12 Reference range above or below the upper limit
- Insulin reference range above or below the upper limit
- More than twice the AST or ALT or Alkaline Phosphatase (ALP) reference range upper limit
- More than 1.5 times the upper limit of the bilirubin total reference range
- A 12-electrode electrocardiogram in the screening period revealed a QTc> 450 ms or clinically significant abnormalities
- Those who are judged to be inadequate to perform the clinical trial when the examiners judge them for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability Among Different Eutropin Formulations in Healthy Male Volunteers
- Compares and evaluates the relative bioavailability of single-dose subcutaneous administration of each of the Eutropin formulations to healthy male volunteers.
- Ensure safety and tolerability of single, subcutaneous administration of Eutropin formulations to healthy male volunteers.
- Conditions
- Relative Bioavailability
- Being tested
- Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IUDrug
Investigate the Relative Bioavailability among Different Eutropin Formulations
| Study group | Role | What they receive |
|---|---|---|
| Eutropin 4IU | Experimental | Not described Receives: Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU |
| Eutropin AQ 12IU | Experimental | Not described Receives: Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU |
| Eutropin Pen 36IU | Experimental | Not described Receives: Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of somatropin
Pharmacokinetic assessment
Measured: Total three period at weekly intervals (Week 1, Week2, Week3)
Secondary outcomes (12)
Peak Plasma Concentration (Cmax) of somatropin
Pharmacokinetic assessment
Measured: Total three period at weekly intervals (Week 1, Week2, Week3)
Area under the plasma concentration versus time curve (AUCinf) of somatropin
Pharmacokinetic assessment
Measured: Total three period at weekly intervals (Week 1, Week2, Week3)
Time at which the Cmax is observed (Tmax) of somatropin
Pharmacokinetic assessment
Measured: Total three period at weekly intervals (Week 1, Week2, Week3)
Elimination half-life time (t1/2β) of somatropin
Pharmacokinetic assessment
Measured: Total three period at weekly intervals (Week 1, Week2, Week3)
IGF-1
Pharmacodynamic assessment
Measured: Total three period at weekly intervals (Week 1, Week2, Week3)
IGF-BP3
Pharmacodynamic assessment
Measured: Total three period at weekly intervals (Week 1, Week2, Week3)
Monitoring of adverse reactions
Clinical significance is assessed by reviewing the general findings of individual subjects individually, and when there is a specific or tendency, analysis is conducted
Measured: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Physical examination
Weight, Height
Measured: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Vital Signs
Left-sided blood pressure (systolic / diastolic), pulse rate, tympanic temperature
Measured: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Electrocardiogram
Ventricular rate, PR interval, QRS, QT/QTc
Measured: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Laboratory test
General blood test, general chemical test, clinical chemistry urinalysis, pancreas test
Measured: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Injection site reaction and Pain scale evaluation
Ask the NRS about the degree of pain and evaluate it as 0-10
Measured: Week 1, Week 2, Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start31 May 2017
- Primary completion10 Jul 2017
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative BioavailabilityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 6x3 Crossover Study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154840
- Sponsor's protocol ID
- LG-HGCL009
- Status last verified
- Jul 2017
- First submitted
- 25 Apr 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability Among Different Eutropin Formulations in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03154840
- Acronym / sponsor ID
- LG-HGCL009
- Conditions
- Relative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 16 May 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.
- Compares and evaluates the relative bioavailability of single-dose subcutaneous administration of each of the Eutropin formulations to healthy male volunteers.
- Ensure safety and tolerability of single, subcutaneous administration of Eutropin formulations to healthy male volunteers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 6x3 Crossover Study
| Arm | Type | Receives |
|---|---|---|
| Eutropin 4IU | Experimental | Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU |
| Eutropin AQ 12IU | Experimental | Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU |
| Eutropin Pen 36IU | Experimental | Drug: Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A healthy male who is at least 19 years old but under 40 years of age at screening visit
- Those who weigh more than 50 kg at screening visit and whose body mass index (BMI) is greater than 19 kg / m2 but less than 28 kg / m2
- The result of the vital signs in the screening period.
- A person who is judged to be clinically insignificant in terms of physical or mental condition when the examinee medically judges the screening period physical examination
- Those who are not clinically significant when the examiner has medically judged the results of examination other than the items described in 17) and 18) of the exclusion criterion in the diagnosis laboratory test results in the screening period
Key exclusion criteria (27 listed)
- Those who with a history or history of diabetes
- Those who with a history or history of malignancy
- Those who with a history or history of musculoskeletal disorders (including epiphyseal closure, scoliosis, etc.)
- Those who with history or history of endocrine system (including hypothyroidism, panhypopituitarism, etc.)
- Those who have a history of skin disease, including psoriasis and contact dermatitis, or who can not exclude the possibility of skin disease under the judgment of the examiner on physical examination conducted at the screening visit.
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 |
|---|---|---|
| Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IUInvestigate the Relative Bioavailability among Different Eutropin Formulations | Drug | Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU |
Primary outcome
AUClast of somatropin
Time frame: Total three period at weekly intervals (Week 1, Week2, Week3)
Pharmacokinetic assessment
12 secondary outcomes
Peak Plasma Concentration (Cmax) of somatropin
Time frame: Total three period at weekly intervals (Week 1, Week2, Week3)
Area under the plasma concentration versus time curve (AUCinf) of somatropin
Time frame: Total three period at weekly intervals (Week 1, Week2, Week3)
Time at which the Cmax is observed (Tmax) of somatropin
Time frame: Total three period at weekly intervals (Week 1, Week2, Week3)
Elimination half-life time (t1/2β) of somatropin
Time frame: Total three period at weekly intervals (Week 1, Week2, Week3)
IGF-1
Time frame: Total three period at weekly intervals (Week 1, Week2, Week3)
IGF-BP3
Time frame: Total three period at weekly intervals (Week 1, Week2, Week3)
Monitoring of adverse reactions
Time frame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Physical examination
Time frame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Vital Signs
Time frame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Electrocardiogram
Time frame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Laboratory test
Time frame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
Injection site reaction and Pain scale evaluation
Time frame: Week 1, Week 2, Week 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
Related trials for Relative Bioavailability
RecruitingPhase 1
A Study to Evaluate Different Oral Formulations of KT-621
Healthy Participants
RecruitingPhase 1
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
Healthy
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 1
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
Psoriasis, Healthy
Active, not recruitingPhase 1
A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation
Cystic Fibrosis
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.
Kyun-Seop Bae principal investigator
AIDS Malignancy Consortium
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 Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU in people with Relative Bioavailability, run by LG Chem 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 7 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 21 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?
Results are not available in the source record.
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?
AUClast of somatropin (time frame: Total three period at weekly intervals (Week 1, Week2, Week3)). 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 21 Jul 2017.