Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC) in Patients With Stable Type 2 Diabetes and Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091920
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

Brief Summary:
To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of 2 treatment regimens of IW-1973 Tablet (40 mg per day) administered orally for 2 weeks to patients with stable type 2 diabetes mellitus and hypertension.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hypertension Drug: IW-1973 Oral Tablet Drug: Placebo Oral Tablet Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Compare the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 2 Dose Regimens of IW-1973 in Patients With Stable Type 2 Diabetes and Hypertension
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: QD/QD

Drug: IW-1973 + Placebo

On Days 1-14: 40 mg taken once daily (QD) in AM and placebo taken QD in PM.

Drug: IW-1973 Oral Tablet
40 mg QD doses of IW-1973

Drug: Placebo Oral Tablet
Placebo Oral Tablet to Match Experimental Drug

Experimental: BID/QD

Drug: IW-1973 + Placebo

On Days 1-7: 20 mg taken in AM and 20 mg taken in PM. On Days 8-14: 40 mg taken QD in AM and placebo taken QD in PM.

Drug: IW-1973 Oral Tablet
20 mg BID and 40 mg QD doses of IW-1973

Drug: Placebo Oral Tablet
Placebo Oral Tablet to Match Experimental Drug

Placebo Comparator: PBO/PBO

Drug: Matching Placebo Oral Tablet

On Days 1-14: Placebo taken in AM and in PM.

Drug: Placebo Oral Tablet
Placebo Oral Tablet to Match Experimental Drug




Primary Outcome Measures :
  1. The number and percentage of all on-study deaths, all Serious Adverse Events (SAEs), and Treatment-Emergent Adverse Events (TEAEs). [ Time Frame: 42 Days ]
    The number and percentage of all on-study deaths, all Serious Adverse Events (SAEs), and Treatment-Emergent Adverse Events (TEAEs). SAEs and TEAEs will be tabulated according to MedDRA System Organ Class and Preferred Term.


Other Outcome Measures:
  1. Change from baseline in 24-hour systolic blood pressure (BP) from ambulatory BP monitoring by dose group compared with PBO during the 14-day dosing period. [ Time Frame: Day -1 (pre-dose), and Days 1, 7, and 14 ]
    Change from baseline in 24-hour systolic blood pressure (BP) from ambulatory BP monitoring by dose group compared with PBO during the 14-day dosing period.

  2. Area under the plasma concentration time curve during a dosing interval (AUCtau). [ Time Frame: BID Day 1 (AM and PM) and Day 7 (AM) time points 0, 1, 3, 6, and 12 hours post-dose; QD Day 1 time points 0, 1, 3, 6, 12, 13, 15, 18, and 24 hours post-dose, Day 7 and Day 14 time points 0, 1, 3, 6, 12, and 24 hours post-dose ]
    Area under the plasma concentration time curve during a dosing interval (AUCtau).

  3. Area under the plasma concentration time curve from time zero to the last measurable plasma concentration (AUClast). [ Time Frame: Time Frame: Day 14 (final dose) time points 0, 1, 3, 6, 12, 24 hours, 7 days (Day 21), and 28 days (Day 42) ]
    Area under the plasma concentration time curve from time zero to the last measurable plasma concentration (AUClast).

  4. Area under the plasma concentration time curve extrapolated to infinity (AUCinf). [ Time Frame: Day 14 (final dose) time points 0, 1, 3, 6, 12, 24 hours, 7 days (Day 21), and 28 days (Day 42 ]
    Area under the plasma concentration time curve extrapolated to infinity (AUCinf).

  5. Maximum plasma concentration (Cmax). [ Time Frame: BID Day 1 (AM and PM) and Day 7 (AM) time points 1, 3, and 6 hours post-dose; QD Day 1, 7, 8, and 14 time points 1, 3, and 6 hours post-dose ]
    Maximum plasma concentration (Cmax).

  6. Trough plasma concentrations at the end of the dosing interval (Ctrough). [ Time Frame: BID Day 1 (AM and PM) and Day 7 (AM and PM) at 12 hours post-dose; QD Day 1, 7, 8, and 14 at 24 hours post-dose ]
    Trough plasma concentrations at the end of the dosing interval (Ctrough).

  7. Time of maximum plasma concentrations (Tmax). [ Time Frame: BID Day 1 (AM and PM) and Day 7 (AM) time points 1, 3, and 6 hours post-dose; QD Day 1, 7, 8, and 14 time points 1, 3, and 6 hours post-dose ]
    Time of maximum plasma concentrations (Tmax).

  8. Apparent terminal elimination phase half-life (t1/2). [ Time Frame: Day 14 (final dose) time points 12 hours, 24 hours, 7 days (Day 21), and 28 days (Day 42) ]
    Apparent terminal elimination phase half-life (t1/2).

  9. Apparent volume of distribution during the terminal phase (Vz/F). [ Time Frame: Day 14 (final dose) time points 0, 1, 3, 6, 12, 24 hours, 7 days (Day 21), and 28 days (Day 42) ]
    Apparent volume of distribution during the terminal phase (Vz/F).

  10. Apparent total body clearance (CL/F). [ Time Frame: Day 14 (final dose) time points 0, 1, 3, 6, 12, and 24 hours ]
    Apparent total body clearance (CL/F).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 screening and check-in and must agree to use protocol-specified contraception throughout the duration of the study
  • Patient's health is stable with no clinically significant findings on physical examination
  • Patient has type 2 (ie, adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner > 6 months before the Screening Visit, is on a stable glycemic control medication, and protocol specified HbA1c values at the Screening Visit
  • Patient has hypertension diagnosed by a physician or nurse practitioner > 6 months before the Screening Visit, and BP within the protocol's acceptable range
  • Patients must be on a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
  • Other inclusion criteria per protocol

Exclusion Criteria:

  • 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
  • Patient is an active smoker or has used any nicotine-containing products (cigarettes, e-cigarettes, vape pens, cigars, chewing tobacco, gum, patches) during the 6 months before Check-in. Use of nicotine is excluded during the study until after the End of Trial Visit.
  • Other exclusion criteria per protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091920


Locations
Layout table for location information
United States, California
ProSciento, Inc.
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Cyclerion Therapeutics

Layout table for additonal information
Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT03091920     History of Changes
Other Study ID Numbers: C1973-202
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases