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NCT Number: NCT02187094

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Horizon Research Group, Inc., Mobile, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TC-6499

Drug

Placebo

Drug

Primary outcomes

  1. The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 90 and 120 min post-GEBT meal

  2. 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.

    Time frame: 4 hrs post-GEBT meal

Sponsors and collaborators

Lead sponsor

Targacept Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2014
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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