Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

An Open-label, Two Period Study to Determine the Excretion Balance and Pharmacokinetics of [14C]-GSK221149A, Administered as Single Doses of an Oral Solution and an Intravenous Infusion to Healthy Female Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00457925

Enrollment

Registered

2007-04-09

Start date

2006-10-31

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labour, Premature, Premature Labor

Keywords

absorption,, metabolism,, excretion, distribution,

Brief summary

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

Interventions

DRUGGSK221149A

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026