Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: VHX-896 and iloperidone; Drug: Iloperidone and VHX-896

• Registration Number: NCT04969211
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-20
• Primary Completion: 2021-10-13
• Study Completion: 2021-10-13
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-08
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Healthy male and/or female participants between 18 to 55 years (inclusive).
• Have a Body Mass Index (BMI) of > 18.0 and < 30.0 kg/m2; (BMI = weight (kg)/ [height (m)]2).
• Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
• Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.

Exclusion Criteria

• Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
• Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
• Pregnant or nursing (lactating) women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A: VHX-896 then iloperidone	VHX-896 and iloperidone	-
Sequence B: Iloperidone then VHX-896	Iloperidone and VHX-896	-

Primary Outcome Measures

Name	Time	Method
Assessment of Safety and Tolerability of a single dose of VHX-896	17 days	As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs
Bioequivalence between VHX-896 tablets relative to iloperidone tablets	96 hours	as measured by plasma concentrations

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Springfield, Missouri, United States