Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat
Status:
Recruiting
Trial end date:
2021-05-31
Target enrollment:
Participant gender:
Summary
Niclosamide is a well-established substance that is a promising candidate for a repurposing
approach to treat COVID-19. Niclosamide is currently marketed as a chewing tablet for the
treatment of intestinal worm infections. The marketed formulation is optimized for minimal
drug substance absorption. A niclosamide solution has been developed that is expected to
release the drug substance more readily and more reproducibly.
Camostat is approved for oral treatment of chronic pancreatitis and reflux oesophagitis in
Japan. Camostat has been shown to effectively block viral replication in a SARS-CoV-2 animal
model. Since the mechanisms of actions are different, it was hypothesized that a combination
of both substances might have an additive or even synergistic effect in the treatment of
COVID-19 patients.
This 3-part study is designed to investigate (1) safety and pharmacokinetics of single
ascending doses of the new niclosamide solution after fasted and fed conditions, (2) the
relative bioavailability of the niclosamide solution compared to the chewing tablet, and (3)
safety and pharmacokinetics of the combination of niclosamide solution and camostat after
multiple doses in healthy volunteers.