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

Gastroparesis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187094
• Other study ID #: TC-6499-12-CLP-005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 30, 2014
• Last updated: May 11, 2015
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: Targacept Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• TC-6499

• Placebo

Locations

Country	Name	City	State
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	Profil Institute for Clinical Research, Inc.	Chula Vista	California
United States	Prefered Research Partners, Inc.	Little Rock	Arkansas
United States	Horizon Research Group, Inc.	Mobile	Alabama
United States	Quality Medical Research	Nashville	Tennessee
United States	Aspen Clinical Research, LLC	Orem	Utah
United States	Wake Research associates, LLC	Raleigh	North Carolina
United States	Ventura Clinical Trials	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Targacept Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hrs post-GEBT meal	No
Secondary	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	No
Secondary	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	No