ClinicalTrials.Veeva

Menu

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

Intra-Cellular Therapies logo

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 in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan.

Enrollment

12 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

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Cohort A1: 10 mg ITI-1284
Experimental group
Treatment:
Drug: ITI-1284 10 mg
Cohort A2: 20 mg ITI-1284
Experimental group
Treatment:
Drug: ITI-1284 20 mg

Trial contacts and locations

1

Loading...

Central trial contact

ITI Clinical Trials

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems