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NCT02213029 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Pharmacokinetics, Pharmacodynamics and Tissue Concentrations of Epelsiban
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT02213029 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 33 participants.
The verdict
NCT02213029, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This multi-cohort phase I study is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of oxytocin and to evaluate epelsiban (GSK557296) potential to reduce subendometrial contractractility induced by oxytocin in healthy female subjects. Additionally tissues concentrations of epelsiban will be determined from endometrial tissue biopsies. Data from this study will inform the identification of the doses of epelsiban to be used in future in-vitro fertilization (IVF) clinical studies. Expected number of subjects to be randomized are: Cohort 1- 10 subjects, Cohort 2a- 10 subjects for each epelsiban arm 25 milligrams (mg), 200mg, 5 for placebo, Cohort 2b- 10 subjects per arm with dose to be determined, cohort 3- 6 subjects. Cohorts 1 and 2 will be double blind (sponsor unblinded) placebo controlled cohorts. Cohort 3 will be an open label cohort, cohort 4 will be a double blind (sponsor unblinded) placebo controlled cohort.
Interventions
- DRUG Placebo
- DRUG Oxytocin
- DRUG Epelsiban
- DRUG Ortho-Cylcen (21)® tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-08-28 |
| Est. Completion | 2016-02-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02213029
The ClinicalTrials.gov registry entry for NCT02213029 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02213029 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02213029 about?
NCT02213029 is a clinical study titled "A Study to Evaluate Pharmacokinetics, Pharmacodynamics and Tissue Concentrations of Epelsiban". This multi-cohort phase I study is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of oxytocin and to evaluate epelsiban (GSK557296) potential to reduce subendometrial contractractility induced by oxytocin in healthy female subjects. Additionally tissues concentrations of epel...
What is the current status of trial NCT02213029?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2014-08-28. Estimated completion is 2016-02-07.
What interventions are being tested in trial NCT02213029?
The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG), Epelsiban (DRUG), Ortho-Cylcen (21)® tablet (DRUG).
Who is sponsoring clinical trial NCT02213029?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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