A Four-way Crossover Food Effect and Bioequivalence Pharmacokinetic Study of Simufilam in Healthy Volunteers

PTI-125-05

This study will compare the pharmacokinetics of the Phase 3 simufilam 100 mg oral tablet when taken fasted versus following a high-fat or low-fat meal. Additionally, the Phase 3 oral tablet will be compared to the Phase 2 oral tablet for bioequivalence under fasted conditions.

2021-05-04

2021-05-11

2021-05-11

Completed

Early phase I

24

Inclusion Criteria: 1. Male or female subjects, Ages ≥ 18 and ≤ 45 years 2. BMI of 18 - 30 Kg/m² 3. Informed consent form (ICF) signed by the subject 4. General health status acceptable for participation in the study as determined by medical history, review of current medication, physical examination, and laboratory results 5. Fluency (oral and written) in English 6. The patient must agree to comply with the drawing of blood samples for the PK assessments, laboratory assessments and plasma biomarkers 7. The subject is willing and able to remain at the study site for the duration of the study Exclusion Criteria: 1. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator. 2. The subject has had a clinically significant illness within 30 days of this study. 3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease. 4. Subject is taking prescription CNS medication. 5. The subject has used alcohol, grapefruit, grapefruit juice, caffeine or xanthinecontaining products 48 h before dosing or intends to use any of these products during the study. 6. The subject has a history of substance abuse or a current positive ethanol breath test or positive urine drug screen. 7. The subject has a positive serum hepatitis B surface antigen or positive HCV antibody test. 8. The subject has a positive HIV test. 9. The subject has a current positive urine cotinine test. 10. The subject has participated in another drug study in the past 30 days. 11. The subject has donated or lost a significant volume of blood (\>450 mL) within 4 weeks of the study. 12. The subject is unwilling to reside in the study unit for the duration of the study or to cooperate fully with the investigator or site personnel. 13. Covid-19 infection within the past 3 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Four-way crossover of Phase 3 tablets under fasted or high-fat or low-fat conditions and the Phase 2 tablet under fasted conditions. Subjects are randomized to a sequence.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-08-22