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NCT02925546 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02925546 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 18 participants.
The verdict
NCT02925546, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
GSK2798745 is being developed as a novel therapeutic intervention for the treatment of pulmonary edema associated with heart failure (HF) and is currently under investigation in the form of a compounded capsule. This is an open-label, randomized, single-dose, crossover study with the purpose to determine the pharmacokinetics (PK) of three 2.4 milligrams (mg) tablet formulations of GSK2798745 in 12 healthy subjects. The three formulations developed for this study will be micronized GSK2798745 active pharmaceutical ingredient (API) (Tablet A), micronized GSK2798745 API with sodium lauryl sulfate (SLS) and hypromellose (Tablet B), milled GSK2798745 API with SLS and hypermellose (Tablet C), and Tablet D, which will be either A/B/C based on interim PK analysis of data from the first three treatment periods. Following a 30-day screening period, subjects will be randomized to one of the 6 treatment sequences: Treatment sequence 1: ABCD, 2=CABD, 3=ACBD, 4=BACD, 5=BCAD, 6=CBAD over three 4-day treatment periods. For treatment period 4, the best formulation based on the interim analysis data from the three treatment periods will be evaluated under fed conditions. Each treatment period will be separated by a minimum of 7 (+14)-day washout period. The total duration of participation in the study will be approximately 11 weeks including the follow-up visit.
Interventions
- DRUG GSK2798745 Micronized API without SLS and hypermellose (Tablet A)
- DRUG GSK2798745 Micronized API with SLS and hypermellose (Tablet B)
- DRUG GSK2798745 milled API without SLS and hypermellose (Tablet C)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-10 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02925546
The ClinicalTrials.gov registry entry for NCT02925546 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 3 interventions - of which GSK2798745 Micronized API without SLS and hypermellose (Tablet A) is the first listed.
NCT02925546 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02925546 about?
NCT02925546 is a clinical study titled "A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets". GSK2798745 is being developed as a novel therapeutic intervention for the treatment of pulmonary edema associated with heart failure (HF) and is currently under investigation in the form of a compounded capsule. This is an open-label, randomized, single-dose, crossover study with the purpose to dete...
What is the current status of trial NCT02925546?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-10. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02925546?
The interventions under investigation include: GSK2798745 Micronized API without SLS and hypermellose (Tablet A) (DRUG), GSK2798745 Micronized API with SLS and hypermellose (Tablet B) (DRUG), GSK2798745 milled API without SLS and hypermellose (Tablet C) (DRUG).
Who is sponsoring clinical trial NCT02925546?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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