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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-01-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Gastroparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

One capsule of placebo administered as a single dose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 mg TC-6499

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

Group Type EXPERIMENTAL

TC-6499

Intervention Type DRUG

5 mg TC-6499

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

Group Type EXPERIMENTAL

TC-6499

Intervention Type DRUG

10 mg TC-6499

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

Group Type EXPERIMENTAL

TC-6499

Intervention Type DRUG

Interventions

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TC-6499

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No