Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers
Sponsor
Vanda Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04849559
Collaborator
Mayo Clinic (Other)
24
1
2
8
3
Study Details
Study Description
Brief Summary
To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
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
Actual Study Start Date
:
Feb 1, 2021
Anticipated Primary Completion Date
:
Oct 1, 2021
Anticipated Study Completion Date
:
Oct 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tradipitant Oral Capsule |
Drug: Tradipitant
Tradipitant Capsule
|
| Placebo Comparator: Placebo Oral Capsule |
Drug: Placebo
Placebo Capsule
|
Outcome Measures
Primary Outcome Measures
- Fasting gastric volume as measured by single photon emission computed tomography (SPECT) [9 Days]
- Accommodation volume as measured by SPECT [9 Days]
- Satiation expressed as volume to fullness as measured by satiation test [9 Days]
- Gastric emptying half-time of solids as measured by scintigraphy [9 Days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanda Investigational Site | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Vanda Pharmaceuticals
- Mayo Clinic
Investigators
- Study Director: Vanda Pharmaceuticals, Vanda Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04849559
Other Study ID Numbers:
- VP-VLY-686-1301
First Posted:
Apr 19, 2021
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vanda Pharmaceuticals