Trials / Completed
CompletedNCT01394055
Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose, 2-Period Crossover Study to Evaluate the Pharmacodynamics of RM-131 Administered to Patients With Diabetic Gastroparesis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Motus Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.
Conditions
- Diabetes Mellitus Type 1 and 2
- Diabetes Mellitus Complications
- Gastroparesis
- Gastrointestinal Motility Disorder
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RM-131 | 100 μg subcutaneously once |
| DRUG | Placebo | Matching placebo volume subcutaneously once |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2012-11-01
- Completion
- 2012-12-01
- First posted
- 2011-07-14
- Last updated
- 2016-09-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01394055. Inclusion in this directory is not an endorsement.