Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
- Registration Number
- NCT02187094
- Lead Sponsor
- Targacept Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 10 mg TC-6499 TC-6499 One capsule of 10 mg TC-6499 administered as a single dose. Placebo Placebo One capsule of placebo administered as a single dose. 5 mg TC-6499 TC-6499 One capsule of 5 mg TC-6499 administered as a single dose. 2 mg TC-6499 TC-6499 One capsule of 2 mg TC-6499 administered as a single dose.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (8)
Quality Medical Research
🇺🇸Nashville, Tennessee, United States
Aspen Clinical Research, LLC
🇺🇸Orem, Utah, United States
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
ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Wake Research associates, LLC
🇺🇸Raleigh, North Carolina, United States