Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with gastroparesis.
This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in diabetic subjects with gastroparesis. The length of study participation for a subject is up to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period, subjects will complete 4 overnight drug assessment visits (treatment arms) where they will receive a randomized single dose of study drug and the GEBT. Each overnight visit will be separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4 dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Horizon Research Group, Inc.
Mobile, Alabama, United States
Prefered Research Partners, Inc.
Little Rock, Arkansas, United States
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States
Ventura Clinical Trials
Ventura, California, United States
The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.
Gastric emptying time will be assessed using the oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT) administered following each treatment.
Time frame: 4 hrs post-GEBT meal
The percent dose excreted as 13-CO2 at specific post-meal time points for each treatment relative to placebo after single dose administration of study drug in each arm.
Time frame: 90 and 120 min post-GEBT meal
The time of maximal rate of 13-CO2 expiration for each treatment relative to placebo after single dose administration of study drug in each arm.
Time frame: 4 hrs post-GEBT meal
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Wake Research associates, LLC
Raleigh, North Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Quality Medical Research
Nashville, Tennessee, United States
Aspen Clinical Research, LLC
Orem, Utah, United States