Trial Outcomes & Findings for Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers (NCT NCT04849559)
NCT ID: NCT04849559
Last Updated: 2024-04-16
Results Overview
Fasting Gastric volume
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
9 Days
Results posted on
2024-04-16
Participant Flow
Participant milestones
| Measure |
Tradipitant
Oral Capsule
Tradipitant: Tradipitant Capsule
|
Placebo
Oral Capsule
Placebo: Placebo Capsule
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Tradipitant
Oral Capsule
Tradipitant: Tradipitant Capsule
|
Placebo
Oral Capsule
Placebo: Placebo Capsule
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Effects of Tradipitant on Satiation, Gastric Volume, Gastric Accommodation, and Gastric Emptying in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Tradipitant
n=13 Participants
Oral Capsule
Tradipitant: Tradipitant Capsule
|
Placebo
n=14 Participants
Oral Capsule
Placebo: Placebo Capsule
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.5 Years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
34.9 Years
STANDARD_DEVIATION 10.70 • n=7 Participants
|
33.7 Years
STANDARD_DEVIATION 10.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 DaysPopulation: Completed subjects
Fasting Gastric volume
Outcome measures
| Measure |
Tradipitant
n=11 Participants
Oral Capsule
Tradipitant: Tradipitant Capsule
|
Placebo
n=13 Participants
Oral Capsule
Placebo: Placebo Capsule
|
|---|---|---|
|
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
|
178.8 mL
Interval 158.0 to 217.0
|
191.1 mL
Interval 169.2 to 216.9
|
PRIMARY outcome
Timeframe: 9 DaysPopulation: Completed subjects
Gastric Accommodation post 300mL Ensure
Outcome measures
| Measure |
Tradipitant
n=11 Participants
Oral Capsule
Tradipitant: Tradipitant Capsule
|
Placebo
n=13 Participants
Oral Capsule
Placebo: Placebo Capsule
|
|---|---|---|
|
Accommodation Volume as Measured by SPECT
|
423.8 mL
Interval 358.5 to 484.1
|
411.0 mL
Interval 358.3 to 476.3
|
PRIMARY outcome
Timeframe: 9 DaysPopulation: Completed subjects
Outcome measures
| Measure |
Tradipitant
n=11 Participants
Oral Capsule
Tradipitant: Tradipitant Capsule
|
Placebo
n=13 Participants
Oral Capsule
Placebo: Placebo Capsule
|
|---|---|---|
|
Satiation Expressed as Volume to Fullness as Measured by Satiation Test
|
592.5 mL
Interval 474.0 to 829.5
|
711.0 mL
Interval 474.0 to 948.0
|
PRIMARY outcome
Timeframe: 9 DaysPopulation: Completed subjects
Gastric Emptying Solids, T50%, Min
Outcome measures
| Measure |
Tradipitant
n=11 Participants
Oral Capsule
Tradipitant: Tradipitant Capsule
|
Placebo
n=13 Participants
Oral Capsule
Placebo: Placebo Capsule
|
|---|---|---|
|
Gastric Emptying Half-time of Solids as Measured by Scintigraphy
|
137.0 minutes
Interval 106.8 to 145.0
|
134.0 minutes
Interval 125.3 to 141.7
|
Adverse Events
Tradipitant
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tradipitant
n=13 participants at risk
Oral Capsule
Tradipitant: Tradipitant Capsule
|
Placebo
n=14 participants at risk
Oral Capsule
Placebo: Placebo Capsule
|
|---|---|---|
|
General disorders
fatigue
|
15.4%
2/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
7.1%
1/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
General disorders
peripheral swelling
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
0.00%
0/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
General disorders
swelling face
|
0.00%
0/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
7.1%
1/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
General disorders
abdominal pain
|
0.00%
0/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
7.1%
1/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Gastrointestinal disorders
diarrhea
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
0.00%
0/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
0.00%
0/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Nervous system disorders
somnolence
|
15.4%
2/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
7.1%
1/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Nervous system disorders
headache
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
7.1%
1/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Nervous system disorders
disturbance in attention
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
0.00%
0/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Nervous system disorders
dizziness postural
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
0.00%
0/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Nervous system disorders
restless leg syndrome
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
0.00%
0/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Psychiatric disorders
depressed mood
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
0.00%
0/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Psychiatric disorders
libido decreased
|
7.7%
1/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
0.00%
0/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
|
Metabolism and nutrition disorders
increased appetite
|
0.00%
0/13 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
7.1%
1/14 • 9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER