Skip to main content
OpenTrials
Completed

NCT Number: NCT02792998

A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects

The objectives of this study are:

Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing

Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Unit

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 at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
  • 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 conditions
  • Other exclusion criteria per protocol

Treatment and study plan

IW-1701

Drug

IW-1701 Tablet

Placebo

Drug

Matching Placebo Tablet

Primary outcomes

  1. Treatment Emergent Adverse Event

    Time frame: 47 Days

  2. Maximum observed plasma concentration [Cmax]

    Time frame: 47 Days

    Maximum observed Plasma Concentration

  3. Area under the plasma concentration time curve during a dosing interval [AUC]

    Time frame: 47 Days

    Area under the plasma concentration time curve during a dosing interval

  4. Time of maximum observed plasma concentration [Tmax]

    Time frame: 47 Days

    Time of maximum observed plasma concentration

  5. Blood Pressure

    Time frame: 47 Days

Sponsors and collaborators

Lead sponsor

Cyclerion Therapeutics

Industry

Registry information

Official study title

A 2-Stage Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Tablets in Healthy Subjects in a Double-blind, Placebo-controlled, Multiple-ascending-dose Stage and an Open-label, Single-dose, Crossover Food-effect Stage

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2016
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.