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NCT05732194 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05732194: Completed Phase 1 study of Healthy Volunteers, sponsored by Intra-Cellular Therapies.
NCT05732194 is a Phase 1 study of Healthy Volunteers that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 32 participants, below the 482-participant average among 283 other Healthy Volunteers 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
NCT05732194, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.
Primary Outcome
Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ITI-333
Study Locations (1)
Florida
- Clinical Site 1 - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2023-09-01 |
| Phase | Phase 1 |
What the finished NCT05732194 record still lists
NCT05732194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05732194 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05732194 about?
NCT05732194 is a clinical study titled "Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers". The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.
What is the current status of trial NCT05732194?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2023-01-18. Estimated completion is 2023-09-01.
What conditions does trial NCT05732194 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05732194?
The interventions under investigation include: Placebo (OTHER), ITI-333 (DRUG).
Who is sponsoring clinical trial NCT05732194?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05732194 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05732194's enrollment target sits among peer trials
32 171st of 283 higher than 99 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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