Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Targacept Inc.

Criteria

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