Trials / Completed
CompletedNCT04934124
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Intra-Cellular Therapies, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ITI-333 | ITI-333 oral solution |
| OTHER | Placebo | Matching placebo |
Timeline
- Start date
- 2020-12-23
- Primary completion
- 2021-08-23
- Completion
- 2021-08-23
- First posted
- 2021-06-22
- Last updated
- 2023-03-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04934124. Inclusion in this directory is not an endorsement.