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NCT04520360 · ClinicalTrials.gov registry record · Phase 1
Bioavailability and Food Effect Study of 3 Types of Carisbamate
A Phase 1 study of Healthy Subjects, sponsored by SK Life Science.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT04520360: Completed Phase 1 study of Healthy Subjects, sponsored by SK Life Science.
NCT04520360 is a Phase 1 study of Healthy Subjects that has completed, run by SK Life Science. The registered enrollment target is 33 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04520360, a Phase 1 study of Healthy Subjects, has completed, sponsored by SK Life Science.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to examine the relative bioavailability of three carisbamate formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and the 300 mg Oral Tablet.
Primary Outcome
To evaluate the safety and tolerability of each carisbamate formulation administered under either fed (Oral Suspension Type 2 and the 300 mg Oral Tablet) or fasted (all formulations) conditions. Evaluation of any abnormal laboratory safety results, ECGs or other incidence of treatment-emergent adverse events will be monitored. Subjects will also be assessed on the risk for suicidality via the C-SSRS (Columbia Suicide Severity Rating Scale)
Conditions Studied
Interventions
- DRUG Carisbamate
Study Locations (1)
Utah
- PRA Health Sciences- Salt Lake City - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-08-27 |
| Est. Completion | 2021-10-06 |
| Phase | Phase 1 |
What the finished NCT04520360 record still lists
NCT04520360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which Carisbamate is the first listed.
NCT04520360 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT04520360 about?
NCT04520360 is a clinical study titled "Bioavailability and Food Effect Study of 3 Types of Carisbamate". This study is designed to examine the relative bioavailability of three carisbamate formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and the 300 mg Oral Tablet.
What is the current status of trial NCT04520360?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2020-08-27. Estimated completion is 2021-10-06.
What conditions does trial NCT04520360 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT04520360?
The interventions under investigation include: Carisbamate (DRUG).
Who is sponsoring clinical trial NCT04520360?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04520360 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04520360's enrollment target sits among peer trials
33 34th of 69 higher than 36 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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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