A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Praliciguat ([14C]-IW-1973) Following a Single Oral Dose in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]-praliciguat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males of any race, between 18 and 55 years of age, inclusive Body mass index between 18 and 32 kg/m2, inclusive Subject is in good health and has no clinically significant findings on physical examination Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 90 days after the final dose of study drug Exclusion Criteria: Any active or unstable clinically significant medical condition Use of any prescribed or non-prescribed medication Additional inclusion/exclusion criteria may apply per protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Male Volunteers<br>Single oral dose of [14C]-praliciguat | Drug: [14C]-praliciguat<br>* 10 mg praliciguat containing approximately 500 μCi of [14C]-praliciguat<br>* Other names: [14C]-IW-1973;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |