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Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers

NCT04932655 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-22

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Cassava Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert G Bass, MD · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2021-05-11
Completion
2021-05-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04932655 on ClinicalTrials.gov