Healthy VolunteerPhase 1/2NCT04849559

Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers

A Phase 1/2 study testing Tradipitant in people with Healthy Volunteer, run by Vanda Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Tradipitant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2021to 24 Sep 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to provide written consent
Body Mass Index (BMI) of 18-35 kg/m2
No medical problems or chronic diseases

Who cannot join

Diagnosis of gastrointestinal diseases
Structural or metabolic diseases that affect the GI system
A positive test for drugs of abuse at screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanda Investigational Site
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: VP-VLY-686-1301: A Single Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers

To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.

Conditions: Healthy Volunteer
Being tested: Tradipitant, Placebo
Keywords: tradipitant, NK-1 antagonist, neurokinin 1 receptor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TradipitantDrug
Tradipitant Capsule
PlaceboDrug
Placebo Capsule

Study groups in NCT04849559
Study group	Role	What they receive
Tradipitant	Experimental	Oral Capsule Receives: Drug: Tradipitant
Placebo	Placebo comparator	Oral Capsule Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
Fasting Gastric volume
Measured: 9 Days
Accommodation Volume as Measured by SPECT
Gastric Accommodation post 300mL Ensure
Measured: 9 Days
Satiation Expressed as Volume to Fullness as Measured by Satiation Test
Measured: 9 Days
Gastric Emptying Half-time of Solids as Measured by Scintigraphy
Gastric Emptying Solids, T50%, Min
Measured: 9 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202124 Sep 2021

First posted19 Apr 2021
Study start1 Feb 2021
Primary completion24 Sep 2021
Study completion24 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteerStudies 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 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: A single center, randomized, double-blind, placebo-controlled study to evaluate the effects of tradipitant on satiation, gastric volume, gastric accommodation and gastric emptying in healthy volunteers
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04849559
Sponsor's protocol ID: VP-VLY-686-1301
Status last verified: Apr 2021
First submitted: 13 Apr 2021
Last updated: 16 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Khanna L, Zheng T, Atieh J, Torres M, Busciglio I, Carlin JL, Xiao M, Harmsen WS, Camilleri M. Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. Aliment Pharmacol Ther. 2022 Jul;56(2):224-230. doi: 10.1111/apt.17065. Epub 2022 May 29.
PubMed 35644931

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VP-VLY-686-1301: A Single Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers
ClinicalTrials.gov ID: NCT04849559
Acronym / sponsor ID: VP-VLY-686-1301
Conditions: Healthy Volunteer
Keywords: tradipitant, NK-1 antagonist, neurokinin 1 receptor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Mayo Clinic
Study start: 1 Feb 2021 (actual)
Primary completion: 24 Sep 2021 (actual)
Study completion: 24 Sep 2021 (actual)
First posted: 19 Apr 2021 (actual)
Results: Posted 16 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: A single center, randomized, double-blind, placebo-controlled study to evaluate the effects of tradipitant on satiation, gastric volume, gastric accommodation and gastric emptying in healthy volunteers

Arm	Type	Receives
Tradipitant	Experimental	Drug: TradipitantOral Capsule
Placebo	Placebo comparator	Drug: PlaceboOral Capsule

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Able to provide written consent
Body Mass Index (BMI) of 18-35 kg/m2
No medical problems or chronic diseases

Key exclusion criteria (3 listed)

Diagnosis of gastrointestinal diseases
Structural or metabolic diseases that affect the GI system
A positive test for drugs of abuse at screening

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
TradipitantTradipitant Capsule	Drug	Tradipitant
PlaceboPlacebo Capsule	Drug	Placebo

Primary outcome

Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
Time frame: 9 Days
Fasting Gastric volume
Accommodation Volume as Measured by SPECT
Time frame: 9 Days
Gastric Accommodation post 300mL Ensure
Satiation Expressed as Volume to Fullness as Measured by Satiation Test
Time frame: 9 Days
Gastric Emptying Half-time of Solids as Measured by Scintigraphy
Time frame: 9 Days
Gastric Emptying Solids, T50%, Min

Results and safety

Results posted to the registry on 16 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tradipitant	13	11
Placebo	14	13

Primary outcome: Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)

Time frame: 9 Days. Median (Inter-Quartile Range). Unit: mL

Measure	Tradipitant n = 11	Placebo n = 13
Value	178.8 (158.0 to 217.0)	191.1 (169.2 to 216.9)

Population analysed: Completed subjects

Primary outcome: Accommodation Volume as Measured by SPECT

Time frame: 9 Days. Median (Inter-Quartile Range). Unit: mL

Measure	Tradipitant n = 11	Placebo n = 13
Value	423.8 (358.5 to 484.1)	411.0 (358.3 to 476.3)

Population analysed: Completed subjects

Primary outcome: Satiation Expressed as Volume to Fullness as Measured by Satiation Test

Time frame: 9 Days. Median (Inter-Quartile Range). Unit: mL

Measure	Tradipitant n = 11	Placebo n = 13
Value	592.5 (474.0 to 829.5)	711.0 (474.0 to 948.0)

Population analysed: Completed subjects

Primary outcome: Gastric Emptying Half-time of Solids as Measured by Scintigraphy

Time frame: 9 Days. Median (Inter-Quartile Range). Unit: minutes

Measure	Tradipitant n = 11	Placebo n = 13
Value	137.0 (106.8 to 145.0)	134.0 (125.3 to 141.7)

Population analysed: Completed subjects

Adverse events

Time frame: 9 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tradipitant	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
Placebo	0 of 14 (0%)	4 of 14 (28.6%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35644931Khanna L, Zheng T, Atieh J, Torres M, Busciglio I, Carlin JL, Xiao M, Harmsen WS, Camilleri M. Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. Aliment Pharmacol Ther. 2022 Jul;56(2):224-230. doi: 10.1111/apt.17065. Epub 2022 May 29.
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.

Vanda Pharmaceuticals study director

Vanda Pharmaceuticals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tradipitant in people with Healthy Volunteer, 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 3 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 16 Apr 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) (time frame: 9 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04849559, which also lists 1 linked publication.

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 16 Apr 2024.