Obstetric Labour, PrematurePhase 1NCT00457925
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
A Phase 1 study testing GSK221149A in people with Obstetric Labour, Premature and Premature Labor, run by GlaxoSmithKline at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labour, Premature, Premature Labor
- What is being tested?
- GSK221149A
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult, non-smoking females
- Aged between 30 - 55 years old, and BMI of between 19 and 32
- Not of child-bearing potential
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.
- Conditions
- Obstetric Labour, Premature, Premature Labor
- Being tested
- GSK221149A
- Keywords
- absorption,, metabolism,, excretion, distribution,
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK221149ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labour, PrematureStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457925
- Sponsor's protocol ID
- OTA105101
- Status last verified
- Feb 2011
- First submitted
- 6 Apr 2007
- Last updated
- 19 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00457925
- Acronym / sponsor ID
- OTA105101
- Conditions
- Obstetric Labour, Premature, Premature Labor
- Keywords
- absorption,, metabolism,, excretion, distribution,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 9 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult, non-smoking females
- Aged between 30 - 55 years old, and BMI of between 19 and 32
- Not of child-bearing potential
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK221149A | Drug | – |
Primary outcome
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).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK221149A in people with Obstetric Labour, Premature and Premature Labor, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.