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A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subject...

Update Il y a 4 ans
Reference: EUCTR2007-002114-19

A phase II, randomized, double-blind, parallel-group, placebo-controlled, 12-week treatment, adaptive proof-of-principle study of twice daily oral dosing of a novel PDE4 inhibitor (ASP9831) in subjects with non-alcoholic steatohepatitis (NASH)

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Extract

Part 1: Objective: To explore exposure to ASP9831 in patients with Non-alcoholic Steatohepatitis (NASH) and to compare the data with healthy volunteer data Part 2: Primary objective: To study the effect of a 12 week treatment with two dose levels of ASP9831 compared to placebo on liver injury by assessing serum levels of Alanine Aminotransferase (ALT) in subjects with NASH

Inclusion criteria

  • Non-alcoholic Steatohepatitis (NASH)

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