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Completed

NCT Number: NCT01440686

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

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

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin

Placebo

Drug

Tablets, oral administrations

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

HanAll BioPharma Co., Ltd.

Industry

Registry information

Official study 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

Acronym: HL-032

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 26, 2011
Registry last updated
Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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