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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01737424
First received: November 27, 2012
Last updated: March 13, 2014
Last verified: March 2014
  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: 12 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: up to 6 days post-dose ] [ Designated as safety issue: No ]
  • AUC [ Time Frame: up to 6 days post-dose ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Experimental: LC28-0126
LC28-0126(IV)
Drug: LC28-0126
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737424

Locations
Korea, Republic of
Seoul National University Hospital, Clinical Trial Center
Seoul, Korea, Republic of, 110-744
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: March 13, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on July 24, 2014