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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Mayo Clinic
Rochester, Minnesota, United States
Pharmacodynamic (PD) effects of RM-131 on gastric emptying
Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)
Time frame: 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
Safety and tolerability of RM-131
Number of participants with adverse events
Time frame: 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
Time frame: 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
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