Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers

NCT ID: NCT04932655

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2021-05-11

Brief 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.

Detailed 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).

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sequence A

This arm received Phase 2 tablet fasted (Period 1), Phase 3 tablet fasted (Period 2), Phase 3 tablet after a high-fat meal (Period 3), and Phase 3 tablet after a low-fat meal (Period 4).

Group Type: OTHER

simufilam

Intervention Type: DRUG

Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.

Sequence B

This arm received Phase 3 tablet after a low-fat meal (Period 1), Phase 2 tablet fasted (Period 2), Phase 3 tablet fasted (Period 3), and Phase 3 tablet after a high-fat meal (Period 4).

Group Type: OTHER

simufilam

Intervention Type: DRUG

Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.

Sequence C

This arm received Phase 3 tablet fasted (Period 1), Phase 3 tablet after a high-fat meal (Period 2), Phase 3 tablet after a low-fat meal (Period 3), and Phase 2 tablet fasted (Period 4).

Group Type: OTHER

simufilam

Intervention Type: DRUG

Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.

Sequence D

This arm received Phase 3 tablet after a high-fat meal (Period 1), Phase 3 tablet after a low-fat meal (Period 2), Phase 2 tablet fasted (Period 3), and Phase 3 tablet fasted (Period 4).

Group Type: OTHER

simufilam

Intervention Type: DRUG

Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PTI-125

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Worldwide Clinical Trials

OTHER

Sponsor Role: collaborator

Cassava Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert G Bass, MD

Role: PRINCIPAL_INVESTIGATOR

Worldwide Clinical Trials

Locations

Worldwide Clinical Trials Phase I Unit

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PTI-125-05

Identifier Type: -

Identifier Source: org_study_id