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

NCT04969211 | Completed Phase 1 FDA Drug

• 1 other identifier: VP-VHX-896-1101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Iloperidone; VHX-896; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Bioequivalence between VHX-896 tablets relative to iloperidone tablets

  as measured by plasma concentrations

  96 hours

• Assessment of Safety and Tolerability of a single dose of VHX-896

  As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs

  17 days

Study Arms (2)

Sequence A: VHX-896 then iloperidone

EXPERIMENTAL

Drug: VHX-896 and iloperidone

Sequence B: Iloperidone then VHX-896

EXPERIMENTAL

Drug: Iloperidone and VHX-896

Interventions

VHX-896 and iloperidone DRUG

oral tablet

Sequence A: VHX-896 then iloperidone

Iloperidone and VHX-896 DRUG

oral tablet

Sequence B: Iloperidone then VHX-896

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (1)

Vanda Investigational Site

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Interventions

iloperidone

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: June 30, 2021
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)