Status:
COMPLETED
A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent.
- Male or female patients 18 to 65 years of age (inclusive).
- Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year.
- Symptomatically stable within the past two months.
Exclusion
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
- Pregnant or nursing (lactating) women.
- A positive test for drugs of abuse.
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04712734
Start Date
January 13 2021
End Date
August 30 2022
Last Update
June 29 2023
Active Locations (3)
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1
Vanda Investigational Site
Garden Grove, California, United States, 92845
2
Vanda Investigational Site
Gaithersburg, Maryland, United States, 20877
3
Vanda Investigational Site
Marlton, New Jersey, United States, 08053