Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02703181 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Epelsiban Administered in Repeat Doses in Healthy Women Volunteers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT02703181: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT02703181 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02703181, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The current study is designed to assess the safety, tolerability and pharmacokinetics (PK) of additional repeat doses of epelsiban in healthy females, and will be the first dosing experience of repeat dosing at higher doses in women with this compound. This study is a 14 day, randomized, placebo-controlled, double blind (sponsor unblind), repeat dose, ascending cohort, dose escalation study in healthy, female volunteers. Upon successful completion of the Screening period, a subject will be enrolled in the study. The study will be composed of three periods: Screening, Treatment and Follow-up. A subject's total time involved in the study will be approximately six weeks. Cohorts will be conducted sequentially. Each subject will be enrolled in only one cohort. Ten subjects will be enrolled in each cohort and randomized to epelsiban (n=8) or placebo (n=2).
Primary Outcome
Blood samples were collected for Cohort 1 and 2 on Days 1, 7, and 14 at Pre-dose ante meridiem (AM), Pre Dose post meridiem (PM), Pre- Dose PM2 (second PM dose \[16h\]), 0.5, 1, 2, 6, 8.5, 10, 14, 16.5, 17 and 24 hours post dose. Blood samples were collected for Cohort 3 on Days 1, 7, and 14 at Pre-dose AM, Pre Dose PM, 0.5, 1, 4, 6, 8, 12.5, 13, 16 and 24 hours post dose.
Interventions
- DRUG Epelsiban (GSK557296)
- DRUG Placebo to match GSK557296
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2015-07-09 |
| Est. Completion | 2015-09-10 |
| Phase | Phase 1 |
What the finished NCT02703181 record still lists
NCT02703181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Epelsiban (GSK557296) is the first listed.
NCT02703181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02703181 about?
NCT02703181 is a clinical study titled "Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Epelsiban Administered in Repeat Doses in Healthy Women Volunteers". The current study is designed to assess the safety, tolerability and pharmacokinetics (PK) of additional repeat doses of epelsiban in healthy females, and will be the first dosing experience of repeat dosing at higher doses in women with this compound. This study is a 14 day, randomized, placebo-co...
What is the current status of trial NCT02703181?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2015-07-09. Estimated completion is 2015-09-10.
What interventions are being tested in trial NCT02703181?
The interventions under investigation include: Epelsiban (GSK557296) (DRUG), Placebo to match GSK557296 (DRUG).
Who is sponsoring clinical trial NCT02703181?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02703181's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI