Clinical trial NCT03154840: Relative Bioavailability Among Different Eutropin Formulations
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relative Bioavailability
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 6x3 Crossover Study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. A healthy male who is at least 19 years old but under 40 years of age at screening visit
2. 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
3. The result of the vital signs in the screening period.
4. 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
5. 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
6. 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
7. Those who voluntarily decide to participate in clinical trials and observe the test subjects' precautions and agree in writing

Exclusion Criteria:

1. Those who with a history or history of diabetes
2. Those who with a history or history of malignancy
3. Those who with a history or history of musculoskeletal disorders (including epiphyseal closure, scoliosis, etc.)
4. Those who with history or history of endocrine system (including hypothyroidism, panhypopituitarism, etc.)
5. 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.
6. 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 /
7. 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.)
8. Those who have participated in other clinical trials or bioequivalence tests within 90 days of the screening visit date
9. Within 60 days before screening visit Those who have received blood (blood, whole blood, etc.) or blood transfusions
10. 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
11. Within 14 days prior to screening visit, special medicines that may affect the clinical trial, or those who use general medicines within 7 days
12. Screening Within 30 days prior to the visiting date Alcohol Abuse (alcohol-containing beverage\> 21 units / week)
13. Over 30 days before screening visit Overcame smoker (cigarette\> 10 cigarettes / day)
14. Within 7 days of screening visit Caffeine-containing foods Excessive intake (caffeinated foods\> 3 times / week)
15. Screening Within 7 days prior to the visit Date of intake of food containing xanthine
16. As a result of urine nicotine test or urine drug screening test during the screening period
17. Screening period serum test (hepatitis B test, human immunodeficiency virus (HIV) test, hepatitis C test, syphilis test) Result positive
18. 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
19. A 12-electrode electrocardiogram in the screening period revealed a QTc\> 450 ms or clinically significant abnormalities
20. Those who are judged to be inadequate to perform the clinical trial when the examiners judge them for other reasons

Primary outcomes:
measure: AUClast of somatropin
timeFrame: Total three period at weekly intervals (Week 1, Week2, Week3)
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of somatropin
timeFrame: Total three period at weekly intervals (Week 1, Week2, Week3)
measure: Area under the plasma concentration versus time curve (AUCinf) of somatropin
timeFrame: Total three period at weekly intervals (Week 1, Week2, Week3)
measure: Time at which the Cmax is observed (Tmax) of somatropin
timeFrame: Total three period at weekly intervals (Week 1, Week2, Week3)
measure: Elimination half-life time (t1/2β) of somatropin
timeFrame: Total three period at weekly intervals (Week 1, Week2, Week3)
measure: IGF-1
timeFrame: Total three period at weekly intervals (Week 1, Week2, Week3)
measure: IGF-BP3
timeFrame: Total three period at weekly intervals (Week 1, Week2, Week3)
measure: Monitoring of adverse reactions
timeFrame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
measure: Physical examination
timeFrame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
measure: Vital Signs
timeFrame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
measure: Electrocardiogram
timeFrame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
measure: Laboratory test
timeFrame: Week -4(Screening), Week 1, Week 2, Week 3, Week 5
measure: Injection site reaction and Pain scale evaluation
timeFrame: Week 1, Week 2, Week 3
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: AIDS Malignancy Consortium
name: Kyun-Seop Bae
role: PRINCIPAL_INVESTIGATOR
References: