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

NCT01603238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • LG Life Sciences

    lead INDUSTRY

Principal Investigators

  • Stuart Mair MBChB · Quotient Bioresearch Clinical Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-05-31
Completion
2011-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01603238 on ClinicalTrials.gov