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

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ClinicalTrials.gov Identifier: NCT02572349
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief Summary:
The objectives of the study are to assess the safety and tolerability of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: IW-1701 Drug: Matching Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Administered Orally as Single Doses to Healthy Subjects
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: IW-1701
Single Dose
Drug: IW-1701
Placebo Comparator: Matching Placebo for IW-1701
Single Dose
Drug: Matching Placebo



Primary Outcome Measures :
  1. Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events [ Time Frame: From baseline up to 8 days ]
    The primary objectives of this study are to assess the safety and tolerability of single ascending dosage levels of IW-1701 versus placebo in healthy subjects.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Between 18 and 60 years old at the Screening Visit;
  • Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception;
  • BMI > 18.5 and < 32.0 kg/m2 at the Screening Visit;
  • In overall good health with no clinically significant laboratory, ECG, or physical exam findings;
  • Other inclusion criteria per protocol.

Exclusion:

  • History of any clinically-significant medical condition;
  • 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): NCT02572349


Locations
United States, Texas
Ironwood Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02572349     History of Changes
Other Study ID Numbers: ICP-1701-101
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Healthy Subjects