Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394055
• Other study ID #: RM-131-003
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2011
• Last updated: September 21, 2016
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2016
• Source: Motus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Key Inclusion Criteria:

• Able to provide written informed consent prior to any study procedures.

• Diagnosis of Type 1 or 2 diabetic gastroparesis.

• Controlled Type 1 or 2 diabetes mellitus (HbA1c <10.1%).

• Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Period 1 (daily adjustments of insulin doses are permitted).

• Body mass index of 18-40 kg/m².

Key Exclusion Criteria:

• Unable or unwilling to provide informed consent or to comply with study procedures.

• History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure. (Note: history of diagnostic endoscopy is not exclusionary).

• Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, poor renal or hepatic function, etc.

• Any clinically significant abnormalities on screening laboratories as determined by the Investigator.

• Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities or blood pressure at screening except minor deviations deemed to be of no clinical significance by the Investigator.

• Poor venous access or inability to tolerate venipuncture.

• Acute GI illness within 48 hours of Period 1.

• Positive pregnancy test.

• Participation in a clinical study within the 30 days prior to dosing in the present study.

• Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus Complications
• Diabetes Mellitus Type 1 and 2
• Diabetes Mellitus, Type 1
• Gastrointestinal Motility Disorder
• Gastroparesis

Intervention

Drug:
• RM-131
100 µg subcutaneously once
• Placebo
Matching placebo volume subcutaneously once

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Motus Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic (PD) effects of RM-131 on gastric emptying	Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)	Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2	No
Secondary	Safety and tolerability of RM-131	Number of participants with adverse events	Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2	Yes
Secondary	Pharmacokinetics (PK) of RM-131	Median T-max of RM-131 levels in patients with type 2 diabetes mellitus	Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2	No