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Last Updated: December 11, 2019

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CLINICAL TRIALS PROFILE FOR IW-1701

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Clinical Trials for IW-1701

Trial ID Title Status Sponsor Phase Summary
NCT02572349 Trial of IW-1701 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers Completed Ironwood Pharmaceuticals, Inc. Phase 1 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.
NCT02792998 A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects Completed Ironwood Pharmaceuticals, Inc. Phase 1 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.
NCT02931565 Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type II Achalasia Not yet recruiting Ironwood Pharmaceuticals, Inc. Phase 2 The objectives of this study are as follows: In patients with primary Type II Achalasia, following a single 5-mg dose of IW-1701, - To assess the safety and tolerability - To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM) - To determine the pharmacokinetic (PK) parameters, Cmax, Tmax, and AUClast
NCT03285178 A Study of the Effect of IW-1701, a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD) Not yet recruiting Ironwood Pharmaceuticals, Inc. Phase 2 The primary objective of the 1701-202 STRONG SCD study is to evaluate the safety and tolerability of 3 dose levels of IW-1701 compared with placebo when administered daily for approximately 12 weeks to patients with stable SCD. Exploratory objectives include evaluation of PK as well as evaluation of the effect of IW-1701 on symptoms of SCD, health-related quality of life, and biomarkers of PD activity.
NCT03795519 A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers Not yet recruiting Ironwood Pharmaceuticals, Inc. Phase 1 The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-olinciguat.
NCT03892499 A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of the Soluble Guanylate Cyclase Stimulator, Olinciguat (IW-1701), in Healthy Volunteers Not yet recruiting Ironwood Pharmaceuticals, Inc. Phase 1 To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics (PK) of olinciguat
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for IW-1701

Condition Name

Condition Name for
Intervention Trials
Healthy 3
Sickle Cell Disease 1
Healthy Volunteers 1
Achalasia 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Anemia, Sickle Cell 1
Esophageal Achalasia 1
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Clinical Trial Locations for IW-1701

Trials by Country

Trials by Country for
Location Trials
United States 6
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Trials by US State

Trials by US State for
Location Trials
Texas 3
Tennessee 1
Illinois 1
Connecticut 1
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Clinical Trial Progress for IW-1701

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 2
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 4
Completed 2
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Clinical Trial Sponsors for IW-1701

Sponsor Name

Sponsor Name for
Sponsor Trials
Ironwood Pharmaceuticals, Inc. 6
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 6
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