We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01603238
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : May 22, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: [14C]-LC15-0444 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2011
Primary Completion Date : May 2011
Study Completion Date : July 2011
Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Cmax [ Time Frame: up to 72h post dose ]
    Whole blood and plasma concentrations of total radioactivity

Secondary Outcome Measures :
  1. Cmax [ Time Frame: up to 72h post dose ]
    Plasma concentrations of parent drug

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603238

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

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01603238     History of Changes
Other Study ID Numbers: LG-DPCL008
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012