Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

GlaxoSmithKline6 enrolled

Overview

This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstetric Labour, Premature Premature Labor

Interventions

GSK221149ADRUG

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Healthy adult, non-smoking females * Aged between 30 - 55 years old, and BMI of between 19 and 32 * Not of child-bearing potential Exclusion criteria: * No clinically significant findings on clinical examination, medical examination and blood tests. * Radiation exposure over previous 3 years is greater than 10mSv * History of bleeding or gastric problems

Locations (1)

GSK Investigational Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Urinary and fecal cumulative excretion as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and fecal samples for assessment of metabolites. Samples are collected for approximately 7 days (or longer).

Secondary Outcomes

Clinical Safety data. PK parameters of GSK221149A and drug-related material (radioactivity) in plasma following oral and intravenous dosing. Samples are collected for approximately seven days (or longer) following dosing.

Data from ClinicalTrials.gov

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