Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932655
• Other study ID #: PTI-125-05
• Status: Completed
• Phase: Phase 1
• Start date: May 4, 2021
• Est. completion date: May 11, 2021

Study information

• Verified date: October 2022
• Source: Cassava Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-center, randomized, four-treatment, four-sequence crossover study in healthy volunteers to estimate the effect of food on the pharmacokinetics of simufilam following oral 100 mg Phase 3 oral tablets. Additionally, the relative bioavailability of the Phase 3 100 mg tablet will be compared to the earlier Phase 2 100 mg 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials Phase I Unit	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Cassava Sciences, Inc.	Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	The maximum concentration determined directly from individual concentration-time data	0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours
Primary	AUClast	Area under the curve to the time of the last quantifiable concentration, calculated using the linear trapezoidal method	0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours
Primary	AUCinf	Area under the curve extrapolated to infinity; calculated as: AUCinf = AUClast + Clast/?z	0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours