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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-09-24

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tradipitant

Oral Capsule

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

Tradipitant Capsule

Placebo

Oral Capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Capsule

Interventions

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Tradipitant

Tradipitant Capsule

Intervention Type DRUG

Placebo

Placebo Capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes