Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
HL-032
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
September 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedOctober 16, 2012
October 1, 2012
3 months
September 23, 2011
October 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the serum hGH(human growth hormone)concentration-time curve
From 0 to the time of the last quantifiable concentration over a 32-hour sampling period
Maximum observed serum hGH concentration
Over a 32-hour sampling period
Secondary Outcomes (2)
Area under the effect(IGF-1, IGFBP-3, NEFA)curve
From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period
Maximum IGF-1, IGFBP-3, NEFA effect
Over a 32-hour sampling period
Study Arms (3)
HL-032 30mg
EXPERIMENTALA single dose 30mg administered orally
HL-032 60mg
EXPERIMENTALA single dose 60mg administered orally
HL-032 120mg
EXPERIMENTALA single dose 120mg administered orally
Interventions
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
Eligibility Criteria
You may qualify if:
- Healthy male subjects
- Age(yr)between 19 and 50
- Signed written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-Sang Yu, Medicine
Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2011
First Posted
September 26, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
October 16, 2012
Record last verified: 2012-10