Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] LC15-0444
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.
|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|
- Cmax [ Time Frame: up to 72h post dose ] [ Designated as safety issue: No ]Whole blood and plasma concentrations of total radioactivity
- Cmax [ Time Frame: up to 72h post dose ] [ Designated as safety issue: No ]Plasma concentrations of parent drug
|Study Start Date:||May 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
A single oral dose of [14C]-LC15-0444 50 mg , containing 4.9 MBq [14C] (batch number 110372/C/01).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603238
|Korea, Republic of|
|LG Life Sciences|
|Seoul, Korea, Republic of, 110-062|
|Principal Investigator:||Stuart Mair MBChB||Quotient Bioresearch Clinical Services|