TZP-101 will be developed as a first-in class therapy for the treatment of gastric dysmotility.
Conditions
Interventions
Product Name: TZP-101 I.V. Injection
Product Code: TZP-101
Pharmaceutical Form: Solution for infusion
Current Sponsor code: TZP-101
Other descriptive name: TZP-101 HCl Monohydrate
Concentration unit:
Sponsors
Tranzyme Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subject (male or female) is 18-80 years old •Subject has type 1 or type 2 diabetes mellitus •Subject has documented diagnosis of gastroparesis (all of the following apply): - Confirmed delayed gastric emptying (properly conducted gastric emptying assessments within last 6 months acceptable) - AND a minimum 3 month history of relevant symptoms for gastroparesis (chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting). - AND a mean Gastroparesis Cardinal Symptom Index (GCSI) Score (2 week recall version) of = 2.66 and a post-prandial fullness/early satiety subscale score of = 3.0 - AND it is confirmed by endoscope that there are no obstructive lesions in the esophagus or stomach (endoscopy within prior 3 months acceptable) •Subject is currently on or has had standard gastroparesis therapy •Subject has never had a gastrectomy, nor major abdominal surgery or any evidence of bowel obstruction within the previous 12 months •Dosage of any concomitant medications has been stable for at least 3 weeks •Albumin level = 2.0 gms/dL •HbA1c level is = 12.5% •Subject has a BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Subject has acute severe gastroenteritis •Subject has a gastric pacemaker •Subject is on chronic parenteral feeding •Subject has daily persistent severe vomiting •Subject has pronounced dehydration •Subject has had diabetic ketoacidosis in last 4 weeks •Subject has a history of eating disorders (anorexia nervosa, binge eating, bulimia) •Subject has a marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval >450 ms for male / >470 ms for female) •Subject has a history of additional risk factors for Torsades de Pointes (heart failure, chronic hypokalemia, family history of Long QT Syndrome) •Subject requires use of concomitant medication that prolongs the QT interval - List provided to clinical sites •Subject has history of cardiovascular ischemia in previous 12 months or acute myocardial infarction (MI) or unstable angina •Subject requires use of concomitant medication that is known to interact with isoenzyme CYP3A4 and the combination with an CYP3A4 inhibitor is known to introduce a clinically significant drug interaction - List provided to clinical sites •Subject has a history of psychiatric disorder or cognitive impairment that would interfere with participation in the study •Subject has a history of alcoholism •Subject is taking regular daily narcotics •Subject has a known history of Hep B, Hep C or HIV •Subject has severely impaired renal function (creatinine clearance 6 seconds over control (INR > 2.3) •Subject has participated in an investigational study within 30 days prior to or received TZP-101 within 90 days prior to study initiation •Subject is pregnant or is breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate safety and efficacy of various doses of TZP- 101 in subjects with severe gastroparesis due to diabetes mellitus.;Secondary Objective: ;Primary end point(s): Change from baseline in the mean GCSI post-prandial fullness/early satiety subscale score across the four days of dosing. Baseline is the mean of the four GCSI post-prandial fullness/early satiety subscale scores (24 hour recall version) across the four days prior to admission for dosing | — |
Countries
Sweden, United Kingdom
Outcome results
None listed