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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorIntra-Cellular Therapies, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Healthy male and female subjects between 18 and 55 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.

Disqualifiers

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 supine 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);

Trial design

Treatments tested in this trial

  • ITI-1284 10 mg
  • ITI-1284 20 mg

Treatment groups

42 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators