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

Healthy Volunteers Clinical Trial

— NIC-002  

Official title:

A 3-part Study to Investigate the Safety and Pharmacokinetics of a Novel Niclosamide Solution as a Treatment Option for COVID-19 in Combination With Camostat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644705
• Other study ID #: 201767
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2020
• Est. completion date: May 3, 2021

Study information

• Verified date: November 2021
• Source: Charité Research Organisation GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Niclosamide
Niclosamide will be applied in various dosage steps, galenic preparations and in combination with camostat
• Placebo
placebo to the interventional drug

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charité Research Organisation GmbH	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent number of Adverse Events	Assessment of severity of an AE will be based on CTCAE Version 5.0	up to 14 days
Primary	Maximum plasma concentration of niclosamide (µg/ml)	Measurement will start at Day 1	from predose until 24 hours after intervention
Primary	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	from predose until 24 hours after intervention
Secondary	Food effect on maximum plasma concentration of niclosamide (µg/ml)	Measurement will start at Day 1 after a standard high fat breakfast	from predose until 24 hours after intervention
Secondary	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	from predose until 24 hours after intervention
Secondary	Maximum plasma concentration of niclosamide (µg/ml) at steady state after multiple dosing		from predose until Day 9
Secondary	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		from predose until Day 9