Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.

Official Title
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Multicenter, Randomized, Double-Blind, Placebo Controlled, Crossover Single Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Effect on Gastric Emptying of TZP-101 IV Infusion in Diabetic Gastroparesis Patients

Conditions
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Gastroparesis, Diabetes Mellitus

Intervention / Treatment
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* Drug: 5% dextrose in water
* Drug: TZP-101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has type 1 or type 2 diabetes mellitus Subject has documented diagnosis of gastroparesis by: Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal) A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting) Subject has normal upper endoscopy If female, must be permanently sterilized or postmenopausa. Exclusion Criteria: Patient has received any investigational drug within the preceding 30 days Patient is taking unstable doses of medication that affects gastric motility Patient has co-morbid condition Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances. Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months. Patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug. Patient has known history of alcoholism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: 5% dextrose in water<br>* 60 ml IV infusion over 30 minutes<br>* Other names: D5W;|
| Experimental: 2<br>TZP-101 | Drug: TZP-101<br>* 1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-lead ECG data |  | 8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal |  | Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delayed gastric emptying, symptomatic gastroparesis, diabetes mellitus