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Completed

NCT Number: NCT04644705

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niclosamide

Drug

Niclosamide will be applied in various dosage steps, galenic preparations and in combination with camostat

Placebo

Drug

placebo to the interventional drug

Primary outcomes

  1. Treatment emergent number of Adverse Events

    Time frame: up to 14 days

    Assessment of severity of an AE will be based on CTCAE Version 5.0

  2. Maximum plasma concentration of niclosamide (µg/ml)

    Time frame: from predose until 24 hours after intervention

    Measurement will start at Day 1

  3. Area Under the Plasma Concentration Time Curve from predose until last detectable concentration of niclosamide(AUC0-last) of niclosamide [µg/ml*h]

    Time frame: from predose until 24 hours after intervention

    Measurement will start at Day 1

Secondary outcomes

  1. Food effect on maximum plasma concentration of niclosamide (µg/ml)

    Time frame: from predose until 24 hours after intervention

    Measurement will start at Day 1 after a standard high fat breakfast

  2. Food effect on Area Under the Plasma Concentration Time Curve from predose until last detectable concentration of niclosamide (AUC0-last) [µg/ml*h]

    Time frame: from predose until 24 hours after intervention

    Measurement will start at Day 1 after a standard high fat breakfast

  3. Maximum plasma concentration of niclosamide (µg/ml) at steady state after multiple dosing

    Time frame: from predose until Day 9

  4. 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

Sponsors and collaborators

Lead sponsor

Charité Research Organisation GmbH

Other

Collaborators

  • Bayer

Registry information

Official study 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

Acronym: NIC-002

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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