Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers

NCT04932655 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PTI-125-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• AUCinf

  Area under the curve extrapolated to infinity; calculated as: AUCinf = AUClast + Clast/λz

  0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours

Study Arms (4)

Sequence A

OTHER

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).

Drug: simufilam

Sequence B

OTHER

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).

Drug: simufilam

Sequence C

OTHER

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).

Drug: simufilam

Sequence D

OTHER

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).

Drug: simufilam

Interventions

simufilam 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.

Also known as: PTI-125

Sequence A; Sequence B; Sequence C; Sequence D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
• The subject has had a clinically significant illness within 30 days of this study.
• The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
• Subject is taking prescription CNS medication.
• 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.
• The subject has a history of substance abuse or a current positive ethanol breath test or positive urine drug screen.
• The subject has a positive serum hepatitis B surface antigen or positive HCV antibody test.
• The subject has a positive HIV test.
• The subject has a current positive urine cotinine test.
• The subject has participated in another drug study in the past 30 days.
• The subject has donated or lost a significant volume of blood (\>450 mL) within 4 weeks of the study.
• 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

Sponsors & Collaborators

• Cassava Sciences, Inc.: lead
• Worldwide Clinical Trials: collaborator

Study Sites (1)

Worldwide Clinical Trials Phase I Unit

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

Simufilam

Results Point of Contact

• Title: Nadav Friedmann, PhD, MD
• Organization: Cassava Sciences, Inc.

eschoen@cassavasciences.com

512-501-2444

Study Officials

• Robert G Bass, MD

  Worldwide Clinical Trials

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 21, 2021
• Study Start: May 4, 2021
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: August 22, 2023
• Results First Posted: August 22, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)