Clinical trial NCT02187094: Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastroparesis
Lead sponsor: Targacept Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.
timeFrame: 4 hrs post-GEBT meal
Secondary outcomes:
measure: 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.
timeFrame: 90 and 120 min post-GEBT meal
measure: 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.
timeFrame: 4 hrs post-GEBT meal
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Horizon Research Group, Inc.
state: Alabama
city: Little Rock
country: United States
facility: Prefered Research Partners, Inc.
state: Arkansas
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research, Inc.
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Raleigh
country: United States
facility: Wake Research associates, LLC
state: North Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Orem
country: United States
facility: Aspen Clinical Research, LLC
state: Utah
Study officials:
References: