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NCT04849559 Clinical Trial

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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04849559
Other study ID # VP-VLY-686-1301
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 1, 2021
Est. completion date September 24, 2021

Study information
Verified date April 2021
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date September 24, 2021
Est. primary completion date September 24, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tradipitant
Tradipitant Capsule
• Placebo
Placebo Capsule

Locations
Country Name City State
United States Vanda Investigational Site Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Vanda Pharmaceuticals Mayo Clinic

Country where clinical trial is conducted

United States, 

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