A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

An Open-label, Positron Emission Tomography (PET) Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After Single Oral Doses of ITI-333 in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470101
• Other study ID #: ITI-333-003
• Status: Recruiting
• Phase: Phase 1
• Start date: July 26, 2022
• Est. completion date: August 2023

Study information

• Verified date: January 2023
• Source: Intra-Cellular Therapies, Inc.
• Contact: ITI Clinical Trials
• Phone: 646-440-9333
• Email: ITCIClinicalTrials[@]itci-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, single-dose study of up to 4 dose levels of ITI-333 in healthy male and female subjects. Each cohort will enroll 6 subjects. Subjects will have a baseline PET/CT scan and a postdose PET/CT scan using [14C]-MDL100907 to characterize 5-HT2A receptor occupancy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects between 18 and 45 years old (inclusive);

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

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

Exclusion Criteria:

• 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;

• History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;

• Any condition which would preclude MRI or PET/CT examination (eg, implanted metal, claustrophobia, unable to fit in PET/CT or MRI scanners).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ITI-333
ITI-333 oral solution

Locations

Country	Name	City	State
United States	Clinical Site 2	Creve Coeur	Missouri
United States	Clinical Site 1	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics: Receptor occupancy (RO)		baseline 90-minute PET scan between Day -5 and Day -1, and a 90-minute PET scan starting at approximately 1 hour postdose
Primary	Pharmacokinetics: AUC0-t	Area under the plasma concentration time curve from time zero to the last measurable of concentration of ITI-333 and its metabolites	predose and multiple timepoints up to 24 hours postdose
Secondary	Percentage of subjects with treatment-emergent adverse events		up to 30 days after last dose
Secondary	Change from baseline in systolic and diastolic blood pressure		Up to Day 7
Secondary	Change from baseline in ECG QT interval		Up to Day 7
Secondary	Change from baseline in aspartate aminotransferase		Up to Day 7
Secondary	Change from baseline in alanine aminotransferase		Up to Day 7