At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
simufilamdrug
Likely dose
simufilam 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Four-way Crossover Food Effect and Bioequivalence Pharmacokinetic Study of Simufilam in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating simufilam for Healthy Volunteers. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsWorldwide Clinical Trials
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartMay 2021
Primary CompletionMay 2021
First PostedJun 2021
TodayJul 2026
First PostedJun 21, 2021
Enrollment StartMay 4, 2021
Primary CompletionMay 11, 2021
TodayJul 2, 2026
Enrollment to primary: 7 daysPosted 5.0 years ago
Interventions
simufilamdrug
Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.