NCT04849559

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 16, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

April 13, 2021

Results QC Date

March 19, 2024

Last Update Submit

March 19, 2024

Conditions

Healthy Volunteer

Keywords

tradipitantNK-1 antagonistneurokinin 1 receptor

Outcome Measures

Primary Outcomes (4)

  • Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)

    Fasting Gastric volume

    9 Days

  • Accommodation Volume as Measured by SPECT

    Gastric Accommodation post 300mL Ensure

    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

    Gastric Emptying Solids, T50%, Min

    9 Days

Study Arms (2)

Tradipitant

EXPERIMENTAL

Oral Capsule

Drug: Tradipitant

Placebo

PLACEBO COMPARATOR

Oral Capsule

Drug: Placebo

Interventions

TradipitantDRUG

Tradipitant Capsule

Tradipitant
PlaceboDRUG

Placebo Capsule

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide written consent
  • Body Mass Index (BMI) of 18-35 kg/m2
  • No medical problems or chronic diseases

You may not qualify if:

  • Diagnosis of gastrointestinal diseases
  • Structural or metabolic diseases that affect the GI system
  • A positive test for drugs of abuse at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanda Investigational Site

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Khanna L, Zheng T, Atieh J, Torres M, Busciglio I, Carlin JL, Xiao M, Harmsen WS, Camilleri M. Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. Aliment Pharmacol Ther. 2022 Jul;56(2):224-230. doi: 10.1111/apt.17065. Epub 2022 May 29.

    PMID: 35644931DERIVED

Results Point of Contact

Title
Vanda Pharmaceuticals
Organization
Vanda Pharmaceuticals
clinicaltrials@vandapharma.com
202-734-3400

Study Officials

  • Vanda Pharmaceuticals

    Vanda Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 19, 2021

Study Start

February 1, 2021

Primary Completion

September 24, 2021

Study Completion

September 24, 2021

Last Updated

April 16, 2024

Results First Posted

April 16, 2024

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)