MedPath

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

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
Drug: Placebo
Registration Number
NCT04849559
Lead Sponsor
Vanda Pharmaceuticals
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
27
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboOral Capsule
TradipitantTradipitantOral Capsule
Primary Outcome Measures
NameTimeMethod
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)9 Days

Fasting Gastric volume

Accommodation Volume as Measured by SPECT9 Days

Gastric Accommodation post 300mL Ensure

Satiation Expressed as Volume to Fullness as Measured by Satiation Test9 Days
Gastric Emptying Half-time of Solids as Measured by Scintigraphy9 Days

Gastric Emptying Solids, T50%, Min

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Vanda Investigational Site

🇺🇸

Rochester, Minnesota, United States

© Copyright 2025. All Rights Reserved by MedPath