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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01440686 |
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Date of registration:
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23/09/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
HL-032 |
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Scientific title:
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A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01440686 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Kyung-Sang Yu, Medicine |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy male subjects
- Age(yr)between 19 and 50
- Signed written informed consent
Exclusion Criteria:
- Known hypersensitivity to Octreotide or hGH(human growth hormone)
- History of Cardiovascular, Respiratory, Renal/Genitourinary, Gastrointestinal,
Neurological/Psychic, cancer
- Alcoholic, smokers or drug abusers
- Other conditions which in the opinion of the investigator preclude enrollment into
the study
Age minimum:
19 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Placebo
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Drug: Somatropin
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Primary Outcome(s)
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Area under the serum hGH(human growth hormone)concentration-time curve
[Time Frame: From 0 to the time of the last quantifiable concentration over a 32-hour sampling period]
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Maximum observed serum hGH concentration
[Time Frame: Over a 32-hour sampling period]
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Secondary Outcome(s)
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Area under the effect(IGF-1, IGFBP-3, NEFA)curve
[Time Frame: From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period]
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Maximum IGF-1, IGFBP-3, NEFA effect
[Time Frame: Over a 32-hour sampling period]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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