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

Vanda Pharmaceuticals27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

TradipitantDRUG

Tradipitant Capsule

PlaceboDRUG

Placebo Capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vanda Investigational Site

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Fasting Gastric volume

Time frame: 9 Days

Accommodation Volume as Measured by SPECT

Gastric Accommodation post 300mL Ensure

Time frame: 9 Days

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

Gastric Emptying Solids, T50%, Min

Time frame: 9 Days

Data from ClinicalTrials.gov

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