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

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.

Study Overview

• Status: Completed
• Conditions: Gastroparesis
• Intervention / Treatment: Drug: Placebo; Drug: TC-6499

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).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Horizon Research Group, Inc.
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Prefered Research Partners, Inc.
  • California
    • Chula Vista, California, United States, 91911
      • Profil Institute for Clinical Research, Inc.
    • Ventura, California, United States, 93003
      • Ventura Clinical Trials
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC
    • Nashville, Tennessee, United States, 37211
      • Quality Medical Research
  • Utah
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; One capsule of placebo administered as a single dose.	Drug: Placebo
Experimental: 2 mg TC-6499; One capsule of 2 mg TC-6499 administered as a single dose.	Drug: TC-6499
Experimental: 5 mg TC-6499; One capsule of 5 mg TC-6499 administered as a single dose.	Drug: TC-6499
Experimental: 10 mg TC-6499; One capsule of 10 mg TC-6499 administered as a single dose.	Drug: TC-6499

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Targacept Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: TC-6499-12-CLP-005