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Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers (HL-032)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01440686
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: Somatropin Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Primary Completion Date : December 2011
Study Completion Date : January 2012


Arms and Interventions

Arm Intervention/treatment
Experimental: HL-032 30mg
A single dose 30mg administered orally
Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Drug: Placebo
Tablets, oral administrations
Experimental: HL-032 60mg
A single dose 60mg administered orally
Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Drug: Placebo
Tablets, oral administrations
Experimental: HL-032 120mg
A single dose 120mg administered orally
Drug: Somatropin
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Drug: Placebo
Tablets, oral administrations


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Maximum observed serum hGH concentration [ Time Frame: Over a 32-hour sampling period ]

Secondary Outcome Measures :
  1. 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 ]
  2. Maximum IGF-1, IGFBP-3, NEFA effect [ Time Frame: Over a 32-hour sampling period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440686


Locations
Korea, Republic of
Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
Investigators
Principal Investigator: Kyung-Sang Yu, Medicine Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
More Information

Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01440686     History of Changes
Other Study ID Numbers: HGR10I_1
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by HanAll BioPharma Co., Ltd.:
Pharmacokinetics
Pharmacodynamics
Safety
Male

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases