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

NCT02187094 | Completed Phase 1

• 1 other identifier: TC-6499-12-CLP-005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Gastroparesis

Outcome Measures

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.

  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 Outcomes (2)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

One capsule of placebo administered as a single dose.

Drug: Placebo

2 mg TC-6499

EXPERIMENTAL

One capsule of 2 mg TC-6499 administered as a single dose.

Drug: TC-6499

5 mg TC-6499

EXPERIMENTAL

One capsule of 5 mg TC-6499 administered as a single dose.

Drug: TC-6499

10 mg TC-6499

EXPERIMENTAL

One capsule of 10 mg TC-6499 administered as a single dose.

Drug: TC-6499

Interventions

TC-6499 DRUG

10 mg TC-6499; 2 mg TC-6499; 5 mg TC-6499

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Targacept Inc.: lead

Study Sites (8)

Horizon Research Group, Inc.

Mobile, Alabama, 36608, United States

Location

Prefered Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Wake Research associates, LLC

Raleigh, North Carolina, 27612, United States

Location

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Quality Medical Research

Nashville, Tennessee, 37211, United States

Location

Aspen Clinical Research, LLC

Orem, Utah, 84058, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 10, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

US (8)