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

Tranzyme

Status and phase

Completed

Phase 1

Conditions

Gastroparesis

Diabetes Mellitus

Treatments

Drug: 5% dextrose in water

Drug: TZP-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00639808

EudraCT 2006-002730-38

TZP-101-CL-002

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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