The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy.
The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4) receptor agonist and is being tested to treat people who have diabetic or idiopathic gastroparesis and who previously reported delay in stomach emptying. This study will look at the gastric emptying time of solids in people who take TAK-954 or placebo. The study will enroll approximately 41 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * TAK-954 0.1 mg * TAK-954 0.3 mg * TAK-954 1 mg * Placebo (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient. This single center trial will be conducted in the United States. The duration of treatment is 3 days and the overall period of evaluation is up to 28 days. The participants will be contacted by telephone (Days 10 to 14) for follow-up assessment. There will be another follow-up phone call for women of childbearing potential (Days 38 to 43).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Mayo Clinic
Rochester, Minnesota, United States
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids
Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.
Time frame: Predose and at multiple time-points post-dose (up to 9 hours) on Day 2
Colonic Geometric Center
The scintigraphic method was used to measure colonic geometric center following a radio-labelled meal. The geometric center (GC) was the weighted average of counts in the different colonic regions, where 0= no radioactivity in the colon and if radioactivity was detected in the colon, 1=all isotope was in the ascending colon and 5=all isotope was in the stool; a high GC indicated faster colonic transit.
Time frame: 4, 24, and 48 hours post-radiolabeled meal on Day 2
Colonic Filling at Hour 6
Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.
Time frame: 6 hours post-radiolabel meal on Day 2
Half-emptying Time (T1/2) of Ascending Colon
T1/2 of ascending colon emptying was estimated by analysis of proportionate emptying over time of counts from the colon. Scintigraphy assessments were used to evaluate the emptying of solids or liquids from ascending colon following a radio-labelled meal.
Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
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Cmax: Maximum Observed Plasma Concentration for TAK-954
Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Ctrough: Observed Plasma Concentration at the End of a Dosing Interval
Time frame: At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3