Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers
Study Details
Study Description
Brief Summary
This is a single-center, randomized, four-treatment, four-sequence crossover study in healthy volunteers to estimate the effect of food on the PK of simufilam following oral 100 mg doses and to estimate its relative bioavailability compared to the earlier Phase 2 simufilam tablet in the fasted state. A total of twenty four (24) healthy volunteers (12 male and 12 female) will be enrolled into this study. Subjects will be randomly assigned to one of four treatment sequences (6 subjects/sequence).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This study will compare the PK 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Fasted Phase 3 simufilam 100 mg tablet dosed under fasted conditions. |
Drug: simufilam
Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.
Other Names:
|
| Other: High Fat Phase 3 simufilam 100 mg tablet dosed 30 min after start of a high-fat meal. |
Drug: simufilam
Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.
Other Names:
|
| Other: Low Fat Phase 3 simufilam 100 mg tablet dosed 30 min after start of a low-fat meal. |
Drug: simufilam
Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.
Other Names:
|
| Other: Phase 2 tablet Phase 2 simufilam 100 mg tablet dosed under fasted conditions. |
Drug: simufilam
Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cmax [24 hours]
The maximum concentration determined directly from individual concentration-time data
- Tmax [24 hours]
Time to reach maximum concentration
- AUClast [24 hours]
Area under the curve to the time of the last quantifiable concentration, calculated using the linear trapezoidal method
- AUCinf [24 hours extrapolated to infinity]
Area under the curve extrapolated to infinity; calculated as: AUCinf = AUClast + Clast/λz
- Clast [24 hours]
The last quantifiable concentration determined directly from individual concentration-time data
- Tlast [24 hours]
Time of the last quantifiable concentration
- λz [24 hours]
The observed elimination rate constant; estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile
- T1/2 [24 hours]
The observed terminal elimination half-life calculated as: T1/2 = ln(2)/λz
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects, Ages ≥ 18 and ≤ 45 years
-
BMI of 18 - 30 Kg/m²
-
Informed consent form (ICF) signed by the subject
-
General health status acceptable for participation in the study as determined by medical history, review of current medication, physical examination, and laboratory results
-
Fluency (oral and written) in English
-
The patient must agree to comply with the drawing of blood samples for the PK assessments, laboratory assessments and plasma biomarkers
-
The subject is willing and able to remain at the study site for the duration of the study
Exclusion Criteria:
-
The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
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The subject has had a clinically significant illness within 30 days of this study.
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The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
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Subject is taking prescription CNS medication.
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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.
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The subject has a history of substance abuse or a current positive ethanol breath test or positive urine drug screen.
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The subject has a positive serum hepatitis B surface antigen or positive HCV antibody test.
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The subject has a positive HIV test.
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The subject has a current positive urine cotinine test.
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The subject has participated in another drug study in the past 30 days.
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The subject has donated or lost a significant volume of blood (>450 mL) within 4 weeks of the study.
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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.
-
Covid-19 infection within the past 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Worldwide Clinical Trials Phase I Unit | San Antonio | Texas | United States | 78217 |
Sponsors and Collaborators
- Cassava Sciences, Inc.
- Worldwide Clinical Trials
Investigators
- Principal Investigator: Robert Bass, MD, Worldwide Clinical Trials
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PTI-125-05