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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT06299410
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • ITI-1284 10 mg — DRUG
    ITI-1284 tablet
  • ITI-1284 20 mg — DRUG
    ITI-1284 tablet

Study Details

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.

Key Dates

Start date
Apr 11, 2024
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1: 10 mg ITI-1284
    Radioligand: \[11C\]-raclopride
  • Experimental: Cohort A2: 20 mg ITI-1284
    Radioligand: \[11C\]-raclopride
  • Experimental: Cohort A3: 30 mg ITI-1284
    Radioligand: \[11C\]-raclopride
  • Experimental: Cohort B1: 20 mg ITI-1284
    Radioligand: \[11C\]-MDL100907
  • Experimental: Cohort B2: 20 mg ITI-1284
    Radioligand: \[11C\]-DASB
  • Experimental: Cohort C1: 20 mg ITI-1284
    Radioligand: \[11C\]-raclopride or \[11C\]-MDL100907

Primary Outcome Measure

% Receptor occupancy [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Site 1New HavenConnecticut06520-

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