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The primary objective is to characterize the pharmacokinetics (PK) of praliciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-praliciguat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Male Volunteers | Experimental | Single oral dose of [14C]-praliciguat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-praliciguat | Drug | 10 mg praliciguat containing approximately 500 μCi of [14C]-praliciguat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of total radioactivity excreted in urine (Aeu) and feces (Aef) | up to Day 15 | |
| Cumulative Aeu and cumulative Aef | up to Day 15 | |
| Percentage of total radioactivity excreted in urine (feu) and feces (fef) | up to Day 15 | |
| Cumulative feu and cumulative fef | up to Day 15 | |
| Percentage of total radioactivity in total excreta (feces + urine) | up to Day 15 | |
| Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of praliciguat in plasma | up to Day 15 | |
| AUC0-inf of total radioactivity in plasma and whole blood | up to Day 15 | |
| AUC from time zero to the last quantifiable concentration (AUC0-last) of praliciguat in plasma | up to Day 15 | |
| AUC0-last of total radioactivity in plasma and whole blood | up to Day 15 | |
| Maximum observed concentration (Cmax) of praliciguat in plasma | up to Day 15 | |
| Cmax of total radioactivity in plasma and whole blood |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of metabolite radioactivity excreted in urine and feces | up to Day 15 | |
| AUC0-inf of metabolite radioactivity levels in plasma | up to Day 15 | |
| AUC0-inf of plasma metabolite radioactivity levels relative to AUC0-inf of plasma total radioactivity (Plasma AUC0-inf Ratio of Metabolite Radioactivity/Total Radioactivity) |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion/exclusion criteria may apply per protocol
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| Name | Affiliation | Role |
|---|---|---|
| John Hanrahan, MD | Ironwood Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| up to Day 15 |
| Time of Cmax (Tmax) of praliciguat in plasma | up to Day 15 |
| Tmax of total radioactivity in plasma and whole blood | up to Day 15 |
| Apparent terminal elimination half-life (t1/2) of praliciguat in plasma | up to Day 15 |
| t1/2 total radioactivity in plasma and whole blood | up to Day 15 |
| Apparent total clearance of praliciguat (CL/F) | up to Day 15 |
| Apparent volume of distribution of praliciguat (Vz/F) | up to Day 15 |
| AUC0-inf of plasma praliciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Praliciguat/Plasma Total Radioactivity) | up to Day 15 |
| AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Blood Total Radioactivity/Plasma Total Radioactivity) | up to Day 15 |
| up to Day 15 |
| Chromatographic retention time of metabolites | up to Day 15 |
| Molecular ion mass of metabolites | up to Day 15 |
| Characteristic mass spectrometry fragmentation ions of metabolites | up to Day 15 |
| Chemical structures (graphical representations showing atom connectivity) proposed for plasma, urine, and feces metabolites | up to Day 15 |
| Number(s) of participants with ≥1 treatment-emergent serious adverse event (SAE) | up to Day 15 |
| Number(s) of participants with ≥1 adverse event (AE) leading to study drug discontinuation | up to Day 15 |
| Number(s) of participants with ≥1 Grade ≥3 AE (per CTCAE v. 5.0) | up to Day 15 |
| Number(s) of participants with ≥1 clinically significant abnormal physical examination finding | up to Day 15 |