ITI-333 for Healthy Subjects

No longer recruiting at 2 trial locations

Overseen By ITI Clinical Trials

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Intra-Cellular Therapies, Inc.

Disqualifiers: Cardiac, Hepatic, Renal, Neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ITI-333, an experimental therapy, to examine its interaction with a specific brain receptor related to serotonin, a chemical that influences mood and behavior. The focus is on healthy individuals to understand how the body processes a single dose of ITI-333. The study includes several groups, each receiving different doses to determine the optimal amount for future research. Individuals who are generally healthy and willing to stay at a research center for a short period may be suitable for this trial. As a Phase 1 trial, this research aims to understand how ITI-333 works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy subjects, it is likely that participants should not be on any regular medications.

Is there any evidence suggesting that ITI-333 is likely to be safe for humans?

Research shows that ITI-333 is generally safe for people. Studies have found that this treatment carries a low risk of misuse and is unlikely to cause safety problems. For instance, it does not lead to physical tolerance or dependence, reducing the likelihood of needing higher doses over time.

While detailed side effects in humans are not fully documented, the treatment prioritizes safety. This trial is in an early stage and primarily aims to confirm the safety and tolerability of ITI-333 at various dose levels in healthy individuals. Previous research suggests that ITI-333 was carefully designed to minimize potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ITI-333 because it offers a novel approach to treating conditions that involve the brain's reward system, such as addiction or mood disorders. Unlike many existing treatments that primarily target neurotransmitters like dopamine or serotonin, ITI-333 works by modulating multiple receptor systems, potentially providing a more balanced effect without the side effects associated with current medications. Additionally, ITI-333 is designed to be taken orally, making it a convenient option for patients. This multi-receptor approach could lead to more effective and safer treatments, which is why scientists are eager to explore its potential.

What evidence suggests that ITI-333 could be effective?

Research has shown that ITI-333 could be a promising treatment for opioid use disorder (OUD). Studies have found that it helps with withdrawal symptoms and reduces the urge to use opioids again. ITI-333 works by partially activating certain brain receptors, managing cravings without causing a high. Importantly, it is not addictive. Early animal studies indicated that ITI-333 does not harm the stomach or lungs and is not used by animals addicted to opioids, suggesting it is safe. Overall, these findings suggest ITI-333 could be an effective and safe option for treating OUD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing to be confined to the clinical research unit for the duration of the inpatient period of the study

BMI inclusive of 18.0-32.0 kg/m2 at screening and a minimum weight of 50 kg

Exclusion Criteria

You have a mental health condition that might make it difficult for you to take part in the study, according to the doctor's opinion.

Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (including history of gastric bypass), pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy

Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) < 96% and respiratory rate < 12 breaths per min

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo a baseline PET/CT scan to assess initial brain receptor status

1 day

1 visit (in-person)

Treatment

Participants receive a single oral dose of ITI-333 followed by a postdose PET/CT scan to evaluate receptor occupancy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics up to 24 hours postdose

1 day

Multiple timepoints up to 24 hours postdose

What Are the Treatments Tested in This Trial?

Interventions

• ITI-333

How Is the Trial Designed?

Group I: Cohort A4: ITI-333 dose to be determined based on Cohort A1, A2 and A3 Experimental Treatment 1 Intervention

Group II: Cohort A3: ITI-333 dose to be determined based on Cohort A1 and A2 Experimental Treatment 1 Intervention

Group III: Cohort A2: ITI-333 dose to be determined based on Cohort A1 Experimental Treatment 1 Intervention

Group IV: Cohort A1: ITI-333 2.25 mg Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11199232/

Pharmacologic profile of ITI-333: a novel molecule for ... ITI-333 mitigates opioid withdrawal/reinstatement, supporting its potential utility as a treatment for OUD.

2. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.4c00480

Discovery of ITI-333, a Novel Orally Bioavailable Molecule ... Compound 5 (ITI-333) when administered alone, was found to dose-dependently increase latency to respond to a nociceptive stimulus (radiant heat) in this assay, ...

3. reporter.nih.gov reporter.nih.gov/project-details/9675407

Development of ITI-333, a μ-opioid Receptor Partial ... The nonclinical profile of ITI-333 suggests a promising medication, lacking abuse liability, with partial agonist activity at MOP receptors useful for treatment ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05732194?tab=results

No Study Results Posted | Multiple Ascending Dose ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

5. scholars.uthscsa.edu scholars.uthscsa.edu/en/publications/pharmacologic-profile-of-iti-333-a-novel-molecule-for-treatment-o/

Pharmacologic profile of ITI-333: a novel molecule for ... ITI-333 did not acutely impair gastrointestinal or pulmonary function (rats) and was not intravenously self-administered by heroin-maintained rats or rhesus ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800059932

ITI 333 - AdisInsight - Springer ITI 333 was a small, an oral modulator, an opioid receptor partial agonist and 5HT2A and D1 receptor antagonist, being developed by Intra-Cellular Therapies ...

7. synapse.patsnap.com synapse.patsnap.com/drug/5ba317646cd04034ab6e1b6dc478c595

ITI-333 - Drug Targets, Indications, Patents The objective of this study is to evaluate pharmacokinetics, safety, and tolerability of different doses of ITI-1020. ITI-333 program: ITI-333, a 5-HT2A ...