Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat

• Status: Recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Charité Research Organisation GmbH
• Collaborator: Bayer
• Treatments: Niclosamide

Criteria

Inclusion Criteria:

• Healthy male or female subjects in good health as determined by past medical history

• physical examination, vital signs and safety lab at screening

• between 18 to 45 years of age

Exclusion Criteria:

• Significant illness

• pregnant or lactating women