PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets

Exclusion Criteria

• •Participation in another clinical trial within 3 months prior to the study, or within 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer. (Time calculated relative to the last dose in the previous clinical trial).
• •Regular daily consumption of more than one liter of xanthine-containing beverages (e.g. chocolates, tea, coffee or cola drinks).
• •Regular daily consumption of more than 5 cigarettes daily.
• •Use of a prescription medicine during the 28 days before the first dose of trial medication or use of an over-the-counter medicine, during the 7 days before the first dose of trial medication.
• •Use of dietary supplements or herbal remedies (such as St John's Wort) known to interfere with the CYP3A4 and/or P-gp metabolic pathway during the 28 days before the first dose of trial medication.
• •Therapies which may impact on the interpretation of study results in the opinion of the Investigator.
• •Medical, social condition, psychiatric disorder or occupational reasons that, in the judgment of the Investigator, is a contraindication to protocol participation, may impair the volunteer's ability to give informed consent or effectively participate in the study, may significantly increase the risk to the volunteer because of participation in the study or may impair interpretation of the study data.
• •Blood pressure and heart rate in supine position at the screening examination outside one (or more) of the ranges 105-136 mm Hg systolic, 58-84 mm Hg diastolic; heart rate 56- 96 beats/min.
• •Febrile illness within 1 week before the start of study treatment.
• •History of relevant diseases of vital organs, of the central nervous system or other organs.
• •Participants with a history of allergies, non-allergic drug reactions, adverse reaction to any drug, or multiple drug allergies.
• •Participants with a hypersensitivity to the investigational drug, related benzimidazole compounds or the control agent and/ or to inactive constituents.
• •Presence or history of drug or alcohol abuse in the last 10 years.
• •Surgery (e.g. stomach bypass) or medical condition that might affect absorption of study drug taken orally.
• •Clinically relevant abnormal medical history, concurrent medical condition, acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the trial or make it unnecessarily hazardous.
• •Relevant pathological abnormalities in the ECG such as a second or third-degree atrioventricular (AV) block, prolongation of the QRS complex over 120 msec or of the QTcF-interval over 450 msec (corrected interval according to Fridericia's formula).
• •Positive test for hepatitis B or C.
• •Positive test for HIV.
• •Positive pregnancy test (WOCBP).
• •Positive stool or urine test for helminth infestation by Kato-Katz, urine filtration or Baermann test.
• •Positive for malaria by thick blood smear.
• •Positive test for (neuro-) cysticercosis.
• •Positive test for echinococcosis.
• •Positive test for onchocerciasis.
• •Presence of abnormal physical findings, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the subject.