Status and phase
Conditions
Treatments
About
The principal aim of this study is to obtain safety and tolerability data when AQ280 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects must satisfy all of the following criteria at the screening visit (and/or at check-in, where noted):
Exclusion criteria
Subjects will be excluded from the study if they satisfy any of the following criteria at the screening visit (or at check-in, where noted):
Medical conditions
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 hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
History of any surgical (eg, stomach or intestinal surgery or resection) or medical condition that would potentially alter absorption, distribution, metabolism, and/or excretion of orally administered drugs. Uncomplicated appendectomy and hernia repair will be allowed. Cholecystectomy will not be allowed.
History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose of IMP.
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) values >1.2 × upper limit of normal (ULN).
Congenital nonhemolytic hyperbilirubinemia (including suspicion of Gilbert's syndrome).
Hemoglobin value, neutrophil count, and/or lymphocyte count <lower limit of normal.
Clinically significant abnormal ECG at screening or check-in.
Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects whose results are compatible with prior immunization may be included at the discretion of the investigator
Current active tuberculosis based on Quantiferon™ tuberculosis Gold test.
Prior/concomitant therapy
Administration of a coronavirus disease 2019 vaccine in the past 30 days prior to the first dose of investigational medicinal product (IMP).
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 prior to the first dose of IMP, unless deemed acceptable by the investigator (or designee).
Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to the first dose of IMP, unless deemed acceptable by the investigator (or designee).
Use or intend to use slow release medications/products considered to still be active within 14 days prior to check in, unless deemed acceptable by the investigator (or designee).
Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to check in, unless deemed acceptable by the investigator (or designee).
Prior/concurrent clinical study experience
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
Have previously completed or withdrawn from this study.
Diet and lifestyle
Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
Smoking >5 cigarettes per day, on average, or use the equivalent tobacco- or nicotine containing products per day.
Ingestion of poppy seed , Seville orange , star fruit-, or grapefruit containing foods or beverages within 7 days prior to check-in.
Other exclusions
Receipt of blood products within 2 months prior to check-in.
Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
Poor peripheral venous access.
Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Primary purpose
Allocation
Interventional model
Masking
66 participants in 8 patient groups
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Central trial contact
Anneli Tinnerholm
Data sourced from clinicaltrials.gov
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