Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: simufilam
Intervention description: Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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