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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: RM-131
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RM-131<br> | Drug: RM-131<br>* 100 μg subcutaneously once<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo volume subcutaneously once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus Type 1 and 2, Delayed Gastric Emptying, Gastroparesis, Gastrointestinal Motility Disorder