A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
NCT07061288 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-12-22
Summary
The purpose of this study is to evaluate the dose levels, safety, and drug levels of KarXT intramuscular injection in participants with Schizophrenia
Conditions
Interventions
- DRUG
-
KarXT
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-03
- Primary Completion
- 2027-06-21
- Completion
- 2027-10-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
NCT00088621 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
NCT00694707 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
NCT01376076 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia
NCT06276361 ·Status: COMPLETED ·Phase: PHASE1
-
A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia
NCT00236587 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT05145413 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
NCT02360319 ·Status: COMPLETED ·Phase: PHASE4
-
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
NCT07344948 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
NCT02109562 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
NCT02873208 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparison of the Pharmacokinetics and Safety of Long-acting Injectable Risperidone When Administered to Gluteal or Deltoid Intramuscular Injection Sites in Stable Schizophrenia Patients.
NCT00843687 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia
NCT00253136 ·Status: COMPLETED ·Phase: PHASE3
-
The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia.
NCT06674694 ·Status: RECRUITING ·Phase: PHASE1
-
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
NCT03593213 ·Status: TERMINATED ·Phase: PHASE3
-
A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients
NCT00653406 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Cariprazine in Schizophrenia
NCT01104779 ·Status: COMPLETED ·Phase: PHASE3
-
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT05304767 ·Status: RECRUITING ·Phase: PHASE3
-
An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia
NCT01129882 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)
NCT05953740 ·Status: COMPLETED ·Phase: PHASE1
-
A Long Term Study of Safety for Long Acting Injectable Risperidone in Patients With Schizophrenia or Schizoaffective Disorder.
NCT00558298 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform
NCT02431702 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Seroquel in First Episode Schizophrenia
NCT00254241 ·Status: COMPLETED ·Phase: PHASE4
-
A Comparison of the Effectiveness and Safety of Injectable Risperidone With That of Risperidone Tablets in the Treatment of Patients With Chronic Schizophrenia
NCT00249223 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Efficacy and Safety of Long-acting Injectable Risperidone and Risperidone Tablets in Patients With Schizophrenia
NCT00240708 ·Status: COMPLETED ·Phase: PHASE3
-
An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia
NCT01646827 ·Status: COMPLETED ·Phase: PHASE1