Overview

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