Gastroparesis
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGTC-6499
DRUGPlacebo
Sponsors
Targacept Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6 months (and Gastroparesis Cardinal Symptoms Index total score \>22) * Gastroparesis confirmed using the GEBT * Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10% * Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT * Body Mass Index (BMI) ≤ 40 * Willingness to remain in clinical research facility for the protocol-required days of treatment and study procedures * Willingness to use a double barrier method of birth control (except post-menopausal females) * Able to understand study procedures and provide written informed consent
Exclusion criteria
* History of abdominal surgery including gastric banding procedure * Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube * Persistent daily vomiting * A history of eating disorder * Recent history of poor control of diabetes * Acute severe gastroenteritis * Have implanted or use any type of gastric electric stimulator * Use of opiates, anticholinergic medications, GLP-1 mimetics or amylin analogs * Use of medications potentially influencing upper gastrointestinal motility or appetite * Allergies or intolerance to egg, wheat, milk, or algae * Pregnant or lactating females * Presence of a clinically significant medical condition at any time during the study * Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs * Participated in an investigational drug study within 30 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm. | 4 hrs post-GEBT meal | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | 4 hrs post-GEBT meal |
Countries
United States
Outcome results
None listed