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

NCT ID: NCT04644705

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Part A is a randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study with 3 planned cohorts.

Part B consists of two randomized, open-label, two-sequence, two-period crossover cohorts comparing the new niclosamide solution with the marketed chewing tablets.

Part C is a randomized, double-blinded, placebo-controlled multiple dose study investigating the safety and pharmacokinetics of the combination of niclosamide solution and camostat over a treatment period of 7 days.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
This three part study has double-blinded (placebo-controlled) and open-label parts.

Study Groups

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Part A: verum niclosamide

The SAD cohorts are planned as follows:

Cohort A1: 200 mg (fasted conditions) Cohort A2: 600 mg (fasted conditions) Cohort A3: 1600 mg (fasted and fed conditions)

Group Type ACTIVE_COMPARATOR

Niclosamide

Intervention Type DRUG

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

Part A: placebo to niclosamide

The SAD cohorts are planned as follows:

Cohort A1: placebo to niclosamide 200 mg (fasted conditions) Cohort A2: placebo to niclosamide 600 mg (fasted conditions) Cohort A3: placebo to niclosamide 1600 mg (fasted and fed conditions)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo to the interventional drug

Part B: verum as solution (niclosamide)

Two different crossover designs are chosen. Both are randomized, open-label, two-sequence, two periods crossover designs comparing the new niclosamide solution with the marketed chewing tablets. Planned doses are 1600 mg once daily (oral solution), 2000 mg once daily (chewing tablets) and 500 mg three times daily of both dosage forms.

Group Type ACTIVE_COMPARATOR

Niclosamide

Intervention Type DRUG

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

Part B: verum as chewing tablet (niclosamide)

Two different crossover designs are chosen. Both are randomized, open-label, two-sequence, two periods crossover designs comparing the new niclosamide solution with the marketed chewing tablets. Planned doses are 1600 mg once daily (oral solution), 2000 mg once daily (chewing tablets) and 500 mg three times daily of both dosage forms.

Group Type ACTIVE_COMPARATOR

Niclosamide

Intervention Type DRUG

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

Part C: verum (niclosamide and camostat)

Subjects will receive the combination of niclosamide solution (planned 500 mg three times daily) + camostat (600 mg three times daily) or placebo over a treatment period of 7 days. The dose of the niclosamide solution depends on the safety and pharmacokinetic results of Part A and B but will not exceed 500 mg three times daily.

Group Type ACTIVE_COMPARATOR

Niclosamide

Intervention Type DRUG

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

Part C: placebo to niclosamide and camostat

Subjects will receive the combination of niclosamide solution (planned 500 mg three times daily) + camostat (600 mg three times daily) or placebo over a treatment period of 7 days. The dose of the niclosamide solution depends on the safety and pharmacokinetic results of Part A and B but will not exceed 500 mg three times daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo to the interventional drug

Interventions

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Niclosamide

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

Intervention Type DRUG

Placebo

placebo to the interventional drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Charité Research Organisation GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maximilian Posch, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charité Research Organisation GmbH

Locations

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Charité Research Organisation GmbH

Berlin, , Germany

Site Status

Countries

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Germany

References

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Walther N, Schultz-Heienbrok R, Stass H, Corman VM, Gassen NC, Muller MA, Drosten C, Witzenrath M, Lee H, Posch MG. Clinical safety and pharmacokinetics of a novel oral niclosamide formulation compared with marketed niclosamide chewing tablets in healthy volunteers: A three-part randomized, double-blind, placebo-controlled trial. PLoS One. 2025 Feb 25;20(2):e0303924. doi: 10.1371/journal.pone.0303924. eCollection 2025.

Reference Type DERIVED
PMID: 39999124 (View on PubMed)

Other Identifiers

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201767

Identifier Type: -

Identifier Source: org_study_id