Trials / Completed
CompletedNCT00639808
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Tranzyme, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 5% dextrose in water | 60 ml IV infusion over 30 minutes |
| DRUG | TZP-101 | 1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2007-07-01
- Completion
- 2008-03-01
- First posted
- 2008-03-20
- Last updated
- 2008-03-20
Locations
3 sites across 2 countries: Denmark, Sweden
Source: ClinicalTrials.gov record NCT00639808. Inclusion in this directory is not an endorsement.