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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Niclosamide will be applied in various dosage steps, galenic preparations and in combination with camostat
placebo to the interventional drug
Charité Research Organisation GmbH
Berlin, Germany
Treatment emergent number of Adverse Events
Assessment of severity of an AE will be based on CTCAE Version 5.0
Time frame: up to 14 days
Maximum plasma concentration of niclosamide (µg/ml)
Measurement will start at Day 1
Time frame: from predose until 24 hours after intervention
Area Under the Plasma Concentration Time Curve from predose until last detectable concentration of niclosamide(AUC0-last) of niclosamide [µg/ml*h]
Measurement will start at Day 1
Time frame: from predose until 24 hours after intervention
Food effect on maximum plasma concentration of niclosamide (µg/ml)
Measurement will start at Day 1 after a standard high fat breakfast
Time frame: from predose until 24 hours after intervention
Food effect on Area Under the Plasma Concentration Time Curve from predose until last detectable concentration of niclosamide (AUC0-last) [µg/ml*h]
Measurement will start at Day 1 after a standard high fat breakfast
Time frame: from predose until 24 hours after intervention
Maximum plasma concentration of niclosamide (µg/ml) at steady state after multiple dosing
Time frame: from predose until Day 9
Area Under the Plasma Concentration Time Curve between two dosing intervals (AUC tau ss) of niclosamide [µg/ml*h] at steady state after multiple dosing
Time frame: from predose until Day 9
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