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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00639808

Enrollment

Registered

2008-03-20

Start date

2006-08-31

Completion date

2008-03-31

Last updated

2008-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Gastroparesis

Keywords

delayed gastric emptying, symptomatic gastroparesis, diabetes mellitus

Brief summary

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.

Interventions

DRUGTZP-101

1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg

DRUG5% dextrose in water

60 ml IV infusion over 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Denmark, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026