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NCT04932655 · ClinicalTrials.gov registry record · Phase 1
Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Cassava Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04932655: Completed Phase 1 study of Healthy Volunteers, sponsored by Cassava Sciences.
NCT04932655 is a Phase 1 study of Healthy Volunteers that has completed, run by Cassava Sciences. The registered enrollment target is 24 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04932655, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Cassava Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The maximum concentration determined directly from individual concentration-time data
Conditions Studied
Interventions
- DRUG simufilam
Study Locations (1)
Texas
- Worldwide Clinical Trials Phase I Unit - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-05-04 |
| Est. Completion | 2021-05-11 |
| Phase | Phase 1 |
What the finished NCT04932655 record still lists
NCT04932655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which simufilam is the first listed.
NCT04932655 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04932655 about?
NCT04932655 is a clinical study titled "Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers". 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.
What is the current status of trial NCT04932655?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-05-04. Estimated completion is 2021-05-11.
What conditions does trial NCT04932655 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04932655?
The interventions under investigation include: simufilam (DRUG).
Who is sponsoring clinical trial NCT04932655?
This trial is sponsored by Cassava Sciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04932655 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04932655's enrollment target sits among peer trials
24 204th of 283 higher than 66 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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