Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

Part of paid clinical trials in Miami, Florida.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT06557902
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Lumateperone 10.5 mg capsule — DRUG
    Lumateperone 10.5 mg capsule, oral administration
  • Lumateperone 21 mg capsule — DRUG
    Lumateperone 21 mg capsule, oral administration
  • Lumateperone 5 mg ODT — DRUG
    Lumateperone 5 mg ODT, oral administration
  • Lumateperone 10.5 mg ODT — DRUG
    Lumateperone 10.5 mg ODT, oral administration
  • Lumateperone 15.5 mg ODT — DRUG
    Lumateperone 5 mg ODT + 10.5 mg ODT, oral administration
  • Lumateperone 21 mg ODT — DRUG
    Lumateperone 21 mg ODT, oral administration

Study Details

Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.

Key Dates

Start date
May 10, 2024
Status verified
Aug 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: Group 1 (10 to less than 13 years)
    Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5
  • Experimental: Group 2 (5 to less than 10 years)
    Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients

Primary Outcome Measure

Pharmacokinetics: Cmax [ Time Frame: Day 5 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Clinical Site 6MiamiFlorida33133-
Clinical Site 7OrlandoFlorida32803-
Clinical Site 1AtlantaGeorgia30331-
Clinical Site 2DecaturGeorgia30030-
Clinical Site 3SavannahGeorgia31405-
Clinical Site 4Saint CharlesMissouri63304-
Clinical Site 5LincolnNebraska68526-
Clinical Site 8EverettWashington98201-

Find similar trials in Miami, FL

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
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