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
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