NCT01603238

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-05-01
• Completion: 2011-07-01
• First posted: 2012-05-22
• Last updated: 2012-05-22

Locations

1 site across 1 country: South Korea