Physiologically-based Pharmacokinetic Modeling of Ivermectin in Healthy Human Volunteers

Inclusion criteria * Age 18-65 years old * Caucasian male or female volunteers * Body mass index (BMI) 18-30 kg/m2, weight ≥ 50 kg * Full mental and legal capacity * Signed informed consent prior to any study related procedure * Ability to communicate in German or English, sufficient to comprehend and adhere to study protocol * Normal physical examination, vital signs, laboratory workup, and electrocardiogram (ECG) (in the opinion of investigator) * No history or presence of surgical or medical conditions that might interfere with absorption, distribution, metabolism, and / or elimination of study drug, and / or which might increase its toxic effects (in the opinion of investigator) * No ongoing or recent (one month) participation in another clinical trial * No loss of blood ≥ 250 ml within the last three months * No known hypersensitivity to study drug or any of its constituents * No other conditions or circumstances that might interfere with compliance with study protocol (in the opinion of investigator) Exclusion criteria * History or presence of hepatic or biliary disease * History of gastrointestinal surgery, specifically cholecystectomy * History or presence of alcohol or drug abuse * History or presence of neurological or psychiatric comorbidities, including psychological therapy * Other clinically significant concomitant disease states (e.g., renal disease, cardiovascular disease, etc.) * Intake of prescribed or over-the-counter medications, herbal preparations, an…