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

Sponsor

Motus Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01394055

Collaborator

(none)

Enrollment

Location

Arms

17.1

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 1 and 2 Diabetes Mellitus Complications Gastroparesis Gastrointestinal Motility Disorder	Drug: RM-131 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RM-131	Drug: RM-131 100 μg subcutaneously once
Placebo Comparator: Placebo	Drug: Placebo Matching placebo volume subcutaneously once

Arm

Intervention/Treatment

Active Comparator: RM-131

Drug: RM-131

100 μg subcutaneously once

Placebo Comparator: Placebo

Drug: Placebo

Matching placebo volume subcutaneously once

Outcome Measures

Primary Outcome Measures

Pharmacodynamic (PD) effects of RM-131 on gastric emptying [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]
Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)

Secondary Outcome Measures

Safety and tolerability of RM-131 [Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2]
Number of participants with adverse events
Pharmacokinetics (PK) of RM-131 [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]
Median T-max of RM-131 levels in patients with type 2 diabetes mellitus

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.