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

Premature Ejaculation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00449709
• Other study ID #: OTA106004
• Status: Terminated
• Phase: Phase 1
• First received: March 19, 2007
• Last updated: March 15, 2012
• Start date: March 2007

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Obstetric Labour, Premature
• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• GSK221149

Locations

Country	Name	City	State
United States	GSK Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.		over a 24 hour period during each study session.
Secondary	Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..		over a 24 hour period during each study session.