A study of a new drug, NPI-001 in healthy volunteers to test its safety and tolerability

Exclusion Criteria19

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• History of significant immediate hypersensitivity to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
• History of alcohol abuse or drug/chemical abuse within 2 years prior to Check in.
• Alcohol consumption of >21 units per week for males and >14 units for females.
• Positive urinary drug screen (confirmed by repeat, if necessary) at Screening (does not include alcohol) or Check in (does include alcohol breath test).
• Liver function test values >1.5 upper limit of normal (ULN) (excluding isolated hyperbilirubinemia) or QTcF >450 milliseconds.
• Positive hepatitis panel and/or positive human immunodeficiency test. Subjects whose results are compatible with prior immunization and not infection may be included at the discretion of the Investigator.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half lives, whichever is longer, prior to Check in.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John’s Wort, within 30 days or 5 half-lives (whichever is longer) prior to Check in, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use any prescription medications/products other than oral, implantable, transdermal, injectable, or intrauterine contraceptives, or hormone replacement therapy, within 14 days prior to Check in, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use any nonprescription medications/products (excluding paracetamol, which is allowed), vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to Check in, unless deemed acceptable by the Investigator (or designee).
• Use of tobacco or nicotine containing products within 3 months prior to Check in and positive urine cotinine test at screening or check-in.
• Receipt of blood products within 2 months prior to Check in.
• Donation of blood from 30 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
• Poor peripheral venous access.
• Have previously completed or withdrawn from this study or any other study investigating NPI 001, and have previously received the investigational product.
• Subjects who, in the opinion of the Investigator and/or Sponsor (or designee), should not participate in this study.
• An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.