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

Primary Purpose

Gastroparesis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TC-6499
Placebo
Sponsored by
Targacept Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Horizon Research Group, Inc.
  • Prefered Research Partners, Inc.
  • Profil Institute for Clinical Research, Inc.
  • Ventura Clinical Trials
  • Wake Research associates, LLC
  • ClinSearch, LLC
  • Quality Medical Research
  • Aspen Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

2 mg TC-6499

5 mg TC-6499

10 mg TC-6499

Arm Description

One capsule of placebo administered as a single dose.

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 30, 2014
Last Updated
May 11, 2015
Sponsor
Targacept Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02187094
Brief Title
Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Targacept Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One capsule of placebo administered as a single dose.
Arm Title
2 mg TC-6499
Arm Type
Experimental
Arm Description
One capsule of 2 mg TC-6499 administered as a single dose.
Arm Title
5 mg TC-6499
Arm Type
Experimental
Arm Description
One capsule of 5 mg TC-6499 administered as a single dose.
Arm Title
10 mg TC-6499
Arm Type
Experimental
Arm Description
One capsule of 10 mg TC-6499 administered as a single dose.
Intervention Type
Drug
Intervention Name(s)
TC-6499
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.
Description
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.
Time Frame
4 hrs post-GEBT meal
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Horizon Research Group, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Prefered Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Profil Institute for Clinical Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Wake Research associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Quality Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Aspen Clinical Research, LLC
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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