Phase 2 N=27 Randomized Quadruple-blind Basic Science

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

Healthy Volunteer

Bottom Line

View on ClinicalTrials.gov: NCT04849559 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcome: Primary: Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) — 178.8; 191.1 mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tradipitant (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanda Pharmaceuticals
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)	178.8; 191.1	—
PRIMARY Accommodation Volume as Measured by SPECT	423.8; 411.0	—
PRIMARY Satiation Expressed as Volume to Fullness as Measured by Satiation Test	592.5; 711.0	—
PRIMARY Gastric Emptying Half-time of Solids as Measured by Scintigraphy	137.0; 134.0	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04849559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.