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NCT05938452 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects
A Phase 1 study of Neurological Disorder, sponsored by Forest Hills Lab.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05938452: Completed Phase 1 study of Neurological Disorder, sponsored by Forest Hills Lab.
NCT05938452 is a Phase 1 study of Neurological Disorder that has completed, run by Forest Hills Lab. The registered enrollment target is 40 participants, below the 544-participant average among 10 other Neurological Disorder trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05938452, a Phase 1 study of Neurological Disorder, has completed, sponsored by Forest Hills Lab.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate) using a single ascending dose (SAD) study (under fasting conditions).
Primary Outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) until 30 days after the last administration of the study medication. 6\. Change from baseline in 12-lead electrocardiogram (ECG).
Conditions Studied
Interventions
- DRUG Glyceryl Tribenzoate
Study Locations (1)
New Jersey
- TKL Research - Bloomfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2023-10-19 |
| Phase | Phase 1 |
What the finished NCT05938452 record still lists
NCT05938452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 544-participant average among 10 other Neurological Disorder trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Neurological Disorder appearing as the primary indexed condition, and to 1 intervention - of which Glyceryl Tribenzoate is the first listed.
NCT05938452 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05938452 about?
NCT05938452 is a clinical study titled "Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects". This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate) using a single ascending dose (SAD) study (under fasting conditions).
What is the current status of trial NCT05938452?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-12-12. Estimated completion is 2023-10-19.
What conditions does trial NCT05938452 study?
This clinical trial studies the following conditions: Neurological Disorder.
What interventions are being tested in trial NCT05938452?
The interventions under investigation include: Glyceryl Tribenzoate (DRUG).
Who is sponsoring clinical trial NCT05938452?
This trial is sponsored by Forest Hills Lab, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05938452 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05938452's enrollment target sits among peer trials
40 9th of 10 higher than 2 of 10 other Neurological Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurological Disorder 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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