To evaluate the impact of escalating doses of IW-1973 on endothelial function [using EndoPAT
to measure fingertip small vessel pulse volume], blood pressure (BP), and heart rate.
Drug: Matching Placebo
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Locations near you
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Full eligibility criteria for NCT02906579
Ages eligible for Study
30 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patient is ambulatory male or female
Patient's body mass index score is >20 and <40 kg/m2 at the Screening Visit
Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
Patient's health is stable with no clinically significant findings on a physical examination
Patient has type 2 (ie adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner > 6 months before the Screening Visit, and an entry HbA1c that does not mandate prompt intervention for improved control
Patient has hypertension diagnosed by a physician or nurse pratictioner > 6 months before the Screening Visit and BP within the protocol's acceptable range
Patients must be on a stable regimen for glycemic control, and a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
Patient has abnormal endothelial function measured by the EndoPAT
Other inclusion criteria per protocol
Patient has a clinically significant active or unstable medical condition that, in the opinion of the Investigator, would preclude trial participation
Patient is on medication(s) that when co-administered with a soluble guanylate cyclase
(sGC) stimulator, could increase the risk of hypotension
Patient has evidence of severe or active end-organ damage attributable to diabetes
Patient has severe renal insufficiency, has undergone renal transplantation, or has planned renal transplantation
Other exclusion criteria per protocol
All locations for NCT02906579
United States (1)
ICON Early Phase Unit
San Antonio, Texas, United States, 78209
View full eligibility
Tris trial is registered with FDA with number: NCT02906579. The sponsor of the trial is Cyclerion Therapeutics and it is looking for 11 volunteers for the current phase.
Official trial title: An Open-label, Phase 2a Trial to Evaluate the Effect of Escalating Doses of IW-1973 on Tolerability, Endothelial Function, and Hemodynamics in Patients With Stable Type 2 Diabetes and Hypertension
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