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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: Tradipitant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04849559

VP-VLY-686-1301

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

Tradipitant

Experimental group

Description:

Oral Capsule

Treatment:

Drug: Tradipitant

Placebo

Placebo Comparator group

Description:

Oral Capsule

Treatment:

Drug: Placebo