Portal Hypertension Clinical Trial
Official title:
A Placebo Controlled, Double-blind, Randomised Trial Investigating Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics After Intravenous Administration of FE 204205 in Patients With Cirrhotic Portal Hypertension
The purpose of this trial is to investigate safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) after intravenous (IV) administration of FE 204205 in patients with cirrhotic portal hypertension.
The trial aimed to evaluate the safety, tolerability, PK and PD of IV FE 204205 in cirrhotic
patients with portal hypertension and was planned in 2 parts:
Part 1 of the trial was open‑label where six subjects were planned to receive three ascending
doses of FE 204205, given as infusion over 2 hours on three consecutive days.
Part 2 was planned as a randomised, placebo‑controlled, double‑blind investigation evaluating
the effects of a single dose of FE 204205 on portal haemodynamics in 20 subjects who would
have received either the maximum tolerated dose (as defined in Part 1) of FE 204205 (n=16) or
placebo (n=4).
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