CompletedPhase 1/2

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

United States27 participantsStarted 2021-02-01

Plain-language summary

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to provide written consent * Body Mass Index (BMI) of 18-35 kg/m2 * No medical problems or chronic diseases Exclusion Criteria: * Diagnosis of gastrointestinal diseases * Structural or metabolic diseases that affect the GI system * A positive test for drugs of abuse at screening

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 9 Days

Accommodation Volume as Measured by SPECT

Timeframe: 9 Days

Satiation Expressed as Volume to Fullness as Measured by Satiation Test

Timeframe: 9 Days

Gastric Emptying Half-time of Solids as Measured by Scintigraphy

Timeframe: 9 Days

Trial details

NCT IDNCT04849559

SponsorVanda Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-24

Results submitted2024-03-19

View on ClinicalTrials.gov More Healthy Volunteer trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 9 Days

Accommodation Volume as Measured by SPECT

Timeframe: 9 Days

Satiation Expressed as Volume to Fullness as Measured by Satiation Test

Timeframe: 9 Days

Gastric Emptying Half-time of Solids as Measured by Scintigraphy

Timeframe: 9 Days