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Completed

NCT Number: NCT02616861

Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers

Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study.

Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ironwood Investigator

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit
  • Subject's body mass index score is > 18.5 and < 30.0 kg/m2 at the Screening Visit
  • Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception
  • Subject is in good health and has no clinically significant findings on a physical examination
  • Other inclusion criteria per protocol

Exclusion criteria

  • History of any clinically significant medical condition
  • Other exclusion criteria per protocol

Treatment and study plan

IW-1973

Drug

IW-1973 Tablet

Matching placebo tablet

Drug

Matching placebo tablet

Primary outcomes

  1. Treatment Emergent Adverse Events

    Time frame: 42 Days

  2. Maximum observed plasma concentration (Cmax)

    Time frame: 42 Days

  3. Blood Pressure

    Time frame: 42 days

  4. Area under the plasma concentration time curve during a dosing interval (AUC)

    Time frame: 42 Days

  5. Time of maximum observed plasma concentration (Tmax)

    Time frame: 42 Days

  6. Heart rate

    Time frame: 42 Days

  7. Serum cGMP

    Time frame: 42 Days

Sponsors and collaborators

Lead sponsor

Cyclerion Therapeutics

Industry

Registry information

Official study title

A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 30, 2015
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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