Obstetric Labour, PrematurePhase 1NCT00449709
A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
A Phase 1 study testing GSK221149 in people with Obstetric Labour, Premature and Premature Ejaculation, run by GlaxoSmithKline at 1 site in United States.
Trial summary
PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labour, Premature, Premature Ejaculation
- What is being tested?
- GSK221149
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and non-pregnant female
- Between the ages of 18 and 50 years old.
- Females may be of child-bearing or non-child-bearing potential.
- Non-smokers
- BMI of between 19 and 30 kg/m2 (weight of greater than 110lbs).
Who cannot join
- History of smoking within past 6 months
- Regular alcohol consumption averaging 7 drinks or more per week
- Subject is positive for hepatitis C antibody, hepatitis B surface antigen, or HIV
- Use of prescription or non-prescription drugs within 14 days of study start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Open-label, Cross-over Study to Assess the Pharmacokinetics of GSK221149 Following Single Oral Doses of Various Modified Release Formulations and a Solution in Healthy Adult Subjects
PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149 is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, the pharmacokinetics of various modified release formulations of GSK221149 will be investigated in healthy non-pregnant adult subjects.
- Conditions
- Obstetric Labour, Premature, Premature Ejaculation
- Being tested
- GSK221149
- Keywords
- Pre-term labor,, modified release formulation, pharmacokinetics,
- Medical subject headings
- Premature Birth, Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK221149Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
Measured: over a 24 hour period during each study session.
Secondary outcomes (1)
Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..
Measured: over a 24 hour period during each study session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startMar 2007
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
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
- NCT00449709
- Sponsor's protocol ID
- OTA106004
- Status last verified
- Feb 2011
- First submitted
- 19 Mar 2007
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- 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
- A Two-part, Open-label, Cross-over Study to Assess the Pharmacokinetics of GSK221149 Following Single Oral Doses of Various Modified Release Formulations and a Solution in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00449709
- Acronym / sponsor ID
- OTA106004
- Conditions
- Obstetric Labour, Premature, Premature Ejaculation
- Keywords
- Pre-term labor,, modified release formulation, pharmacokinetics,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- First posted
- 21 Mar 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.
PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149 is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, the pharmacokinetics of various modified release formulations of GSK221149 will be investigated in healthy non-pregnant adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males and non-pregnant female
- Between the ages of 18 and 50 years old.
- Females may be of child-bearing or non-child-bearing potential.
- Non-smokers
- BMI of between 19 and 30 kg/m2 (weight of greater than 110lbs).
Key exclusion criteria (4 listed)
- History of smoking within past 6 months
- Regular alcohol consumption averaging 7 drinks or more per week
- Subject is positive for hepatitis C antibody, hepatitis B surface antigen, or HIV
- Use of prescription or non-prescription drugs within 14 days of study start
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 |
|---|---|---|
| GSK221149 | Drug | – |
Primary outcome
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
Time frame: over a 24 hour period during each study session.
1 secondary outcome
Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..
Time frame: over a 24 hour period during each study session.
Results and safety
The study was stopped early. Results are not available in the source record.
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 GSK221149 in people with Obstetric Labour, Premature and Premature Ejaculation, 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 5 inclusion and 4 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: stopped early, 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 was stopped early. Results are not available in the source record.
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?
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session. (time frame: over a 24 hour period during each study session.). 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.