NCT06494397CompletedPhase 1
Crossover Bioequivalence Study of 12 mg VHX-896 and Iloperidone Tablets Under Steady-State Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Vanda Pharmaceuticals
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Bioequivalence between VHX-896 tablets relative to iloperidone tablets
Study Overview
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 disorder under steady state conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Sequence A: VHX-896 then iloperidone
Experimental
Intervention: VHX-896 and iloperidone (Drug)
Sequence B: Iloperidone then VHX-896
Experimental
Intervention: Iloperidone and VHX-896 (Drug)
Outcomes
Primary Outcomes
Bioequivalence between VHX-896 tablets relative to iloperidone tablets
Time Frame: 12 hours
As measured by plasma concentrations
Secondary Outcomes
- Assessment of safety and tolerability of VHX-896 and iloperidone(24 days)
Investigators
Study Sites (1)
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