Trial Profile
An Open-label Study to Determine the Pharmacokinetics, Safety and Tolerability of Single Ascending Doses of a Subcutaneous Injection of Lumateperone Long-Acting Injectable (LAI) Formulation in Patients With Schizophrenia
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 07 Dec 2022
Price :
$35
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At a glance
- Drugs Lumateperone (Primary) ; Lumateperone
- Indications Schizophrenia
- Focus Pharmacokinetics
- Sponsors Intra-Cellular Therapies
- 01 Dec 2022 Status changed from recruiting to completed.
- 03 Nov 2022 According to an Intra-Cellular Therapies, Inc media release, the company have completed a Phase 1 single ascending dose study.
- 07 Apr 2022 Number of treatment arms have been increased from 3 to 4 by the addition of Experimental: Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper arm. 6 new primary pharmacokinetic end-points have been added.