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

March 15, 2012 updated by: GlaxoSmithKline

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
over a 24 hour period during each study session.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
over a 24 hour period during each study session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

March 19, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 21, 2007

Study Record Updates

Last Update Posted (Estimate)

March 19, 2012

Last Update Submitted That Met QC Criteria

March 15, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTA106004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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