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Pharmacology

Safety, Tolerability, and Pharmacokinetics of a Novel Oral Amphotericin B Formulation (iCo-019) following Single-Dose Administration to Healthy Human Subjects: an Alternative Approach to Parenteral Amphotericin B Administration

Peter Hnik, Ellen K. Wasan, Kishor M. Wasan
Peter Hnik
aiCo Therapeutics Inc., Vancouver, British Columbia, Canada
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Ellen K. Wasan
bCollege of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
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Kishor M. Wasan
aiCo Therapeutics Inc., Vancouver, British Columbia, Canada
cFaculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada
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DOI: 10.1128/AAC.01450-20
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ABSTRACT

This study evaluated the safety, tolerability, and pharmacokinetics of a novel oral amphotericin B (AmB) formulation (iCo-019) following single doses to healthy humans. The data from this study suggest that iCo-019 has a long circulation time and systemic exposure without the associated gastrointestinal, liver, and kidney toxicity associated with AmB. This novel oral AmB formulation can serve as a new treatment strategy to overcome the limitations of the use of parenterally administered AmB products.

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Safety, Tolerability, and Pharmacokinetics of a Novel Oral Amphotericin B Formulation (iCo-019) following Single-Dose Administration to Healthy Human Subjects: an Alternative Approach to Parenteral Amphotericin B Administration
Peter Hnik, Ellen K. Wasan, Kishor M. Wasan
Antimicrobial Agents and Chemotherapy Sep 2020, 64 (10) e01450-20; DOI: 10.1128/AAC.01450-20

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Safety, Tolerability, and Pharmacokinetics of a Novel Oral Amphotericin B Formulation (iCo-019) following Single-Dose Administration to Healthy Human Subjects: an Alternative Approach to Parenteral Amphotericin B Administration
Peter Hnik, Ellen K. Wasan, Kishor M. Wasan
Antimicrobial Agents and Chemotherapy Sep 2020, 64 (10) e01450-20; DOI: 10.1128/AAC.01450-20
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KEYWORDS

phase I human clinical trials
oral amphotericin B
safety and tolerability
pharmacokinetics
healthy human subjects
antimicrobial safety

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