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A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT00449709
Recruitment Status : Terminated
First Posted : March 21, 2007
Last Update Posted : March 19, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obstetric Labour, Premature Premature Ejaculation Drug: GSK221149 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2007



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449709


Locations
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United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00449709     History of Changes
Other Study ID Numbers: OTA106004
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: February 2011
Keywords provided by GlaxoSmithKline:
Pre-term labor,
modified release formulation
pharmacokinetics,
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders