Heart Failure, Congestive Clinical Trial
Official title:
An Open Label, Randomized, Single Dose, Crossover Study to Determine the Pharmacokinetics of Three Tablet Formulations of GSK2798745 in Healthy Subjects
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01357850 -
A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure
|
Phase 2 | |
| Recruiting |
NCT00532688 -
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
|
Phase 2/Phase 3 | |
| Completed |
NCT00531661 -
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
|
N/A | |
| Terminated |
NCT00383630 -
Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure
|
Phase 2 | |
| Completed |
NCT00159614 -
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
|
Phase 2 | |
| Completed |
NCT00149435 -
Cardiovascular Health Study (CHS) Events Follow-up Study
|
||
| Terminated |
NCT00125437 -
Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy
|
N/A | |
| Completed |
NCT00241761 -
Epidemiology of Depression and Heart Failure in Aging
|
N/A | |
| Completed |
NCT00202579 -
Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure
|
Phase 2 | |
| Terminated |
NCT00357591 -
Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation
|
N/A | |
| Completed |
NCT00094263 -
Long-Term Predictors of Morbidity in Older Age
|
N/A | |
| Completed |
NCT00048425 -
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
|
Phase 3 | |
| Completed |
NCT00023556 -
Genetic Architecture of Heart Disease in Rural Brazil
|
N/A | |
| Completed |
NCT00530426 -
Heart Failure Registry
|
Phase 4 | |
| Terminated |
NCT00190359 -
Growth Hormone and Heart Failure
|
N/A | |
| Completed |
NCT00004562 -
Occluded Artery Trial (OAT)
|
Phase 3 | |
| Completed |
NCT00005265 -
Natural History of Coronary Heart Disease
|
N/A | |
| Completed |
NCT02772068 -
Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a
|
Early Phase 1 | |
| Completed |
NCT01074307 -
A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea
|
Phase 4 | |
| Completed |
NCT00502255 -
Telemonitoring in Patients With Heart Failure
|
N/A |