Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] LC15-0444

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01603238
First received: May 17, 2012
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

This was an open-label, non-randomised, single-dose study in 6 healthy male subjects. Subjects attended a screening visit within 28 days before drug administration. Subjects were admitted to the clinical unit on the morning of the day before dosing (Day -1) and received a single oral administration of study drug in a fasted state on Day 1. Subjects were resident in the clinic for up to 7 days after dosing; they could be discharged sooner if a mass balance cumulative recovery of >95% was achieved, or if a mass balance cumulative recovery of >90% was achieved and <1% was collected within 2 separate, consecutive 24 h periods. At specified times during the study period, blood samples were taken and urine and faeces were collected for PK analysis. Safety assessments were also performed.


Condition Intervention Phase
Healthy
Drug: [14C]-LC15-0444
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single-Dose, Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] LC15-0444

Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Cmax [ Time Frame: up to 72h post dose ] [ Designated as safety issue: No ]
    Whole blood and plasma concentrations of total radioactivity


Secondary Outcome Measures:
  • Cmax [ Time Frame: up to 72h post dose ] [ Designated as safety issue: No ]
    Plasma concentrations of parent drug


Enrollment: 6
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [14C]-LC15-0444
A single oral dose of [14C]-LC15-0444 50 mg , containing 4.9 MBq [14C] (batch number 110372/C/01).
Drug: [14C]-LC15-0444
A single oral administration of [14C]-LC15-0444 50 mg, containing 4.9 MBq [14C]. Subjects in the fasted state will receive the drug as a capsule, with 240 ml of water.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male subjects aged 30 to 65
  2. Body Mass Index (BMI) of 18-35 kg/m2
  3. Must be willing and able to communicate and participate in the whole study
  4. Must provide written informed consent
  5. Subject must agree to use an adequate method of contraception, during the study and for 12 weeks after the last dose of the investigational drug. Male subjects will be instructed to use appropriate contraception, including a barrier method (condom), in addition to any precautions taken by their partner;
  6. Normal (or abnormal but not clinically significant) supine blood pressure (BP) and heart rate (HR)
  7. Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination),electrocardiogram (ECG) and laboratory investigations (haematology, blood chemistry and urinalysis).

Exclusion Criteria:

  1. Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months
  2. Subjects who have previously been enrolled in this study
  3. History of any drug or alcohol abuse in the past 2 years
  4. Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine);
  5. Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months)
  6. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at admission
  7. Radiation exposure from clinical studies, including that from the present study,excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01603238

Locations
Korea, Republic of
LG Life Sciences
Seoul, Korea, Republic of, 110-062
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Stuart Mair MBChB Quotient Bioresearch Clinical Services
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01603238     History of Changes
Other Study ID Numbers: LG-DPCL008
Study First Received: May 17, 2012
Last Updated: May 21, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on October 23, 2014