Skip to main content
OpenTrials
Completed

NCT Number: NCT04849559

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vanda Investigational Site

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tradipitant

Drug

Tradipitant Capsule

Placebo

Drug

Placebo Capsule

Primary outcomes

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

    Time frame: 9 Days

    Fasting Gastric volume

  2. Accommodation Volume as Measured by SPECT

    Time frame: 9 Days

    Gastric Accommodation post 300mL Ensure

  3. Satiation Expressed as Volume to Fullness as Measured by Satiation Test

    Time frame: 9 Days

  4. Gastric Emptying Half-time of Solids as Measured by Scintigraphy

    Time frame: 9 Days

    Gastric Emptying Solids, T50%, Min

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Collaborators

  • Mayo Clinic

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.