Status:
COMPLETED
Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Schizophrenia
Bipolar I Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I di...
Eligibility Criteria
Inclusion
- Male or female patients 18 to 65 years of age (inclusive)
- Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type, according to the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-5-TR)
- Patients must be symptomatically stable and on a stable treatment with an oral atypical antipsychotic at an adequate dose (3 months prior to enrollment) and not suffer from acute increase of their psychosis or be hospitalized within the past 2 months
Exclusion
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Cytochrome P450 2D6 (CYP2D6) poor metabolizers and use of prescription medication or OTC medication that strongly inhibits CYP2D6 or CYP3A4 or induces CYP3A4 within 5 half-lives of baseline
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06494397
Start Date
July 11 2024
End Date
October 24 2024
Last Update
September 19 2025
Active Locations (3)
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1
Vanda Investigational Site
Los Alamitos, California, United States, 90720
2
Vanda Investigational Site
Gaithersburg, Maryland, United States, 20877
3
Vanda Investigational Site
Marlton, New Jersey, United States, 08053