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

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ClinicalTrials.gov Identifier: NCT02792998
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief Summary:

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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: IW-1701
IW-1701 tablets administered orally in multiple ascending dose.
Drug: IW-1701
IW-1701 Tablet

Placebo Comparator: Placebo
Matching placebo tablets administered orally.
Drug: Placebo
Matching Placebo Tablet




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02792998


Locations
United States, Texas
ICON Early Phase Unit
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02792998     History of Changes
Other Study ID Numbers: ICP-1701-102
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016