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PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

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Intra-Cellular Therapies

Status and phase

Enrolling
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: ITI-1284 20 mg
Drug: ITI-1284 10 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06299410
ITI-1284-008

Details and patient eligibility

About

The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.

Full description

This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at two dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C (optional) will evaluate the time course of receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and female subjects between 18 and 50 years old (inclusive);
  • BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
  • Willingness to remain in the hospital research unit for the duration of the inpatient period.

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, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
  • Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or pulse rate > 100 bpm or < 45 bpm at Screening;
  • 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);
  • Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET/CT scan.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

30 participants in 5 patient groups

Cohort A1: 10 mg ITI-1284
Experimental group
Description:
Radioligand: \[11C\]-raclopride
Treatment:
Drug: ITI-1284 10 mg
Cohort A2: 20 mg ITI-1284
Experimental group
Description:
Radioligand: \[11C\]-raclopride
Treatment:
Drug: ITI-1284 20 mg
Cohort B1: 20 mg ITI-1284
Experimental group
Description:
Radioligand: \[11C\]-MDL100907
Treatment:
Drug: ITI-1284 20 mg
Cohort B2: 20 mg ITI-1284
Experimental group
Description:
Radioligand: \[11C\]-DASB
Treatment:
Drug: ITI-1284 20 mg
Cohort C: 20 mg ITI-1284
Experimental group
Description:
Radioligand: \[11C\]-MDL100907 or \[11C\]-raclopride
Treatment:
Drug: ITI-1284 20 mg

Trial contacts and locations

1

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Central trial contact

ITI Clinical Trials

Data sourced from clinicaltrials.gov

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