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Study to Investigate the Safety and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

This study is not yet open for participant recruitment.
Verified November 2012 by LG Life Sciences
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01737424
First received: November 27, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in healthy male subjects


Condition Intervention Phase
Healthy
 Drug: LC28-0126
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Blocked-randomized, Double-blind, Placebo-controlled, Single Dosing and Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: up to 2 days post-dose ] [ Designated as safety issue: No ]
  • AUC [ Time Frame: up to 2 days post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: December 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Experimental: LC28-0126
LC28-0126(IV)
 Drug: LC28-0126

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects between the ages of 20 and 45 years at screening.
  • Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive)

Exclusion Criteria:

  • Participation in a clinical research study within the previous 2 months
  • Regular alcohol consumption >21 units per week.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737424

Locations
Korea, Republic of
Seoul National University Hospital, Clinical Trial Center Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang-Heon Cho, M.D., Ph.D.     82-2-2072-4170     shcho123@snu.ac.kr    
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D.            
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01737424     History of Changes
Other Study ID Numbers: LG-CYCL001
Study First Received: November 27, 2012
Last Updated: November 28, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on May 22, 2013