Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04934124 · ClinicalTrials.gov registry record · Phase 1
Single 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
- 48
- Enrollment target
- 1
- Study location
NCT04934124 is a Phase 1 study of Healthy Volunteers that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 48 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04934124, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 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 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a fast of at least 10 hours.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ITI-333
Study Locations (1)
New Jersey
- Clinical Site - Eatontown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-12-23 |
| Est. Completion | 2021-08-23 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04934124
The ClinicalTrials.gov registry entry for NCT04934124 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
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.
NCT04934124 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT04934124 about?
NCT04934124 is a clinical study titled "Single 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 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a ...
What is the current status of trial NCT04934124?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-12-23. Estimated completion is 2021-08-23.
What conditions does trial NCT04934124 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04934124?
The interventions under investigation include: Placebo (OTHER), ITI-333 (DRUG).
Who is sponsoring clinical trial NCT04934124?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04934124 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
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.
-
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
RECRUITING · Phase 1
-
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
RECRUITING · Phase 1
-
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
RECRUITING · Phase 1
-
Classroom Break, Cognition, and Fitness in Elementary School Children
RECRUITING · Phase 1
-
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.