HealthyPhase 1NCT04969211
Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers
A Phase 1 study testing VHX-896 and iloperidone and Iloperidone and VHX-896 in people with Healthy, run by Vanda Pharmaceuticals at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VHX-896 and iloperidone and Iloperidone and VHX-896
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to 13 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanda Investigational Site
Springfield, Missouri, 65802
About this study
Official title: An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers
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
- Being tested
- VHX-896 and iloperidone, Iloperidone and VHX-896
- Keywords
- Iloperidone, VHX-896, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VHX-896 and iloperidoneDrug
oral tablet
Iloperidone and VHX-896Drug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: VHX-896 then iloperidone | Experimental | Not described Receives: Drug: VHX-896 and iloperidone |
| Sequence B: Iloperidone then VHX-896 | Experimental | Not described Receives: Drug: Iloperidone and VHX-896 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence between VHX-896 tablets relative to iloperidone tablets
as measured by plasma concentrations
Measured: 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
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start30 Jun 2021
- Primary completion13 Oct 2021
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969211
- Sponsor's protocol ID
- VP-VHX-896-1101
- Status last verified
- Jul 2022
- First submitted
- 9 Jul 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04969211
- Acronym / sponsor ID
- VP-VHX-896-1101
- Conditions
- Healthy
- Keywords
- Iloperidone, VHX-896, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: VHX-896 then iloperidone | Experimental | Drug: VHX-896 and iloperidone |
| Sequence B: Iloperidone then VHX-896 | Experimental | Drug: Iloperidone and VHX-896 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VHX-896 and iloperidoneoral tablet | Drug | Sequence A: VHX-896 then iloperidone |
| Iloperidone and VHX-896oral tablet | Drug | Sequence B: Iloperidone then VHX-896 |
Primary outcome
Bioequivalence between VHX-896 tablets relative to iloperidone tablets
Time frame: 96 hours
as measured by plasma concentrations
Assessment of Safety and Tolerability of a single dose of VHX-896
Time frame: 17 days
As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VHX-896 and iloperidone and Iloperidone and VHX-896 in people with Healthy, run by Vanda Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence between VHX-896 tablets relative to iloperidone tablets (time frame: 96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.