Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers

A Phase 1, Open Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects

A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects

Inclusion Criteria:

• 1. Healthy subjects with absence of clinically relevant abnormalities as determined by the Investigator or medically qualified designee based on a detailed medical history and complete physical examination;
• 2. Clinical laboratory test results for liver and renal function within the normal reference range. For all other clinical laboratory parameters, results outside the normal reference range to be confirmed by the Investigator and the Sponsor as not clinically significant;
• 3. Male or female subjects ≥18 and ≤55 years of age with a minimum body weight of 50 kg and a body mass index of ≥18.0 to ≤30.0 kg/m2 at the time of signing the informed consent form (ICF);
• 4. Subjects willing and able to comprehend and sign informed consent and to comply with the requirements of this study.

Exclusion Criteria:

• 1. Significant history or clinical manifestation of any metabolic (including thyroid), allergic, dermatological, hepatic (including Gilbert's syndrome), renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal, neurological, or psychiatric disorder;

• 2. Experienced an acute illness within 14 days of SCR;

• 3. Positive serologic test for hepatitis B surface antigen, or for hepatitis C virus antibody, or human immunodeficiency virus I and II at SCR; positive coronavirus disease 2019 test at Day -1 of Part 1 or Part 2;

• 4. Frequent headaches (more than twice a month) and/or migraines, recurrent nausea and/or vomiting, or diarrhea;

• 5. Smokers, defined as having used tobacco- or nicotine-containing products within 6 months prior to SCR;

• 6. Out-of-range vital signs at rest (ie, supine for at least 5 minutes) at SCR and Day -1 of Part 1 and Part 2, defined as:

  1. Systolic blood pressure (SBP) <90 mm Hg or >140 mm Hg;
  2. Diastolic blood pressure (DBP) <50 mm Hg or >90 mm Hg;
  3. Pulse rate <50 bpm or >90 bpm; For these parameters, out-of-range values that are not clinically significant (as determined by the Investigator) may be repeated twice during SCR and the subject may be enrolled if at least one repeated value is within the range noted above;

• 7. Symptomatic hypotension at SCR, regardless of the decrease of blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP ≥20 mm Hg or DBP ≥10 mm Hg within 3 minutes when changing from the supine to the standing position;

• 8. Out-of-range 12-lead electrocardiogram (ECG) recordings at SCR defined as:

  1. PR ≤120 ms or ≥220 ms;
  2. QRS >120 ms;
  3. QT interval corrected for heart rate using Fridericia's method ≥450 ms; For these parameters, out-of-range values that are not clinically significant (as determined by the Investigator) may be repeated twice during SCR and Day -1 and the subject may be enrolled if at least 1 repeated value is within the normal ranges noted above; Subjects must also have no sign of any clinically significant irregularity in heart rhythm.

• 9. Use of any prescription or nonprescription drugs or substances (including vitamins and dietary or herbal supplements) within 30 days or 5 half-lives, if known, of the respective drug or substance, whichever is longer, prior to investigational medicinal product (IMP) administration, unless deemed acceptable by the Investigator and Sponsor;

• 10. Vaccination with a live vaccine within 6 months prior to first dosing or vaccination with an inactivated vaccine (eg, inactivated influenza vaccines or severe acute respiratory syndrome coronavirus 2 vaccines) within 30 days prior to first dosing;

• 11. Receipt of NTZ, or any investigational product within 30 days, or 5 half-lives, if known, of the respective investigational product, whichever is longer, prior to SCR;

• 12. History of alcohol consumption defined as >30 g pure alcohol/day for men, and >20 g pure alcohol/day for women within the last year, or any alcohol consumption within 48 hours prior to SCR or Day -1 for Part 1 and Part 2;

• 13. Consumption of caffeine- or xanthine-containing products (>4 cups or glasses per day of eg, coffee, tea, cola drinks, and chocolate) within 48 hours prior to SCR or Day -1 for Part 1 and Part 2;

• 14. Subjects following a vegan or vegetarian diet or any other dietary restrictions;

• 15. Strenuous exercise within 24 hours prior to SCR or Day -1 for Part 1 and Part 2;

• 16. Blood donation or blood loss (excluding volume drawn at SCR) of 50 to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to IMP administration;

• 17. Receipt of blood products within 2 months prior to SCR;

• 18. History of a major surgical procedure within 6 months prior to SCR. (NOTE: subjects may have had a cholecystectomy, provided not within 3 months of SCR and no complications with cholecystectomy);

• 19. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (eg, bariatric-metabolic surgery, etc.);

• 20. Poor peripheral venous access;

• 21. Known hypersensitivity to the IMP or any of its formulation excipients;

• 22. History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the subject at undue risk;

• 23. Pregnancy or lactation;

• 24. Women of childbearing potential and non-sterile men who are not willing to use adequate contraception for the full duration of the study and for 90 days after the last dose of IMP.