Healthy Volunteer
Conditions
Keywords
tradipitant, NK-1 antagonist, neurokinin 1 receptor
Brief summary
To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.
Interventions
DRUGTradipitant
Tradipitant Capsule
DRUGPlacebo
Placebo Capsule
Sponsors
Mayo Clinic
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) | 9 Days | Fasting Gastric volume |
| Accommodation Volume as Measured by SPECT | 9 Days | Gastric Accommodation post 300mL Ensure |
| 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 | Gastric Emptying Solids, T50%, Min |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tradipitant Oral Capsule
Tradipitant: Tradipitant Capsule | 13 |
| Placebo Oral Capsule
Placebo: Placebo Capsule | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Tradipitant | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 32.5 Years STANDARD_DEVIATION 9.61 | 33.7 Years STANDARD_DEVIATION 10.07 | 34.9 Years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 24 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 6 Participants | 13 Participants | 7 Participants |
| Region of Enrollment United States | 13 participants | 27 participants | 14 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 4 / 13 | 4 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Accommodation Volume as Measured by SPECT
Gastric Accommodation post 300mL Ensure
Time frame: 9 Days
Population: Completed subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tradipitant | Accommodation Volume as Measured by SPECT | 423.8 mL |
| Placebo | Accommodation Volume as Measured by SPECT | 411.0 mL |
Primary
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
Fasting Gastric volume
Time frame: 9 Days
Population: Completed subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tradipitant | Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) | 178.8 mL |
| Placebo | Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) | 191.1 mL |
Primary
Gastric Emptying Half-time of Solids as Measured by Scintigraphy
Gastric Emptying Solids, T50%, Min
Time frame: 9 Days
Population: Completed subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tradipitant | Gastric Emptying Half-time of Solids as Measured by Scintigraphy | 137.0 minutes |
| Placebo | Gastric Emptying Half-time of Solids as Measured by Scintigraphy | 134.0 minutes |
Primary
Satiation Expressed as Volume to Fullness as Measured by Satiation Test
Time frame: 9 Days
Population: Completed subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tradipitant | Satiation Expressed as Volume to Fullness as Measured by Satiation Test | 592.5 mL |
| Placebo | Satiation Expressed as Volume to Fullness as Measured by Satiation Test | 711.0 mL |