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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00449709

Purpose

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	Intervention	Phase
Premature Ejaculation	Drug: GSK221149	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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:

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. ]

Estimated Enrollment:	36
Study Start Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449709

Locations

United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OTA106004
Study First Received:	March 19, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00449709
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Pre-term labor,
pharmacokinetics,
modified release formulation

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Mental Disorders
Obstetric Labor, Premature
Healthy

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 14, 2009