A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics of IW-1973.

Official Title
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An Open-label, 2-Period, Fixed-sequence, Phase 1 Study in Healthy Volunteers to Evaluate the Effect of Itraconazole, a Potent CYP3A Inhibitor, on the Pharmacokinetics of IW-1973

Conditions
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Healthy

Intervention / Treatment
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* Drug: IW-1973
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is an ambulatory adult between 18 and 75 years old at the screening visit Subject is in good health and has no clinically significant findings on physical examination Body mass index is > 18 and < 30.0 kg/m2 at the screening visit Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 2 months after the final dose of study drug Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 2 months after the final dose of study drug Other inclusion criteria per protocol Exclusion Criteria: Any active or unstable clinically significant medical condition Use of any prescribed or non-prescribed medication Other exclusion criteria per protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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 Volunteers<br>Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose. | Drug: IW-1973<br>* Oral Tablet<br>Drug: Itraconazole<br>* Oral Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf]) |  | Predose and up to 14 days post dose of IW-1973 | 
| Maximum Observed Plasma Concentration (Cmax) of IW-1973 |  | Predose and up to 14 days post dose of IW-1973 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cmax (Tmax) of IW-1973 |  | Predose and up to 14 days post dose of IW-1973 | 
| Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973 |  | Predose and up to 14 days post dose of IW-1973 | 
| Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973 |  | Predose and up to 14 days post dose of IW-1973 | 
| Apparent Terminal Half-Life (t1/2) of IW-1973 |  | Predose and up to 14 days post dose of IW-1973 | 
| Apparent Terminal Rate Constant (lambda[z]) of IW-1973 |  | Predose and up to 14 days post dose of IW-1973 | 
| Apparent Total Plasma Clearance (CL/F) of IW-1973 |  | Predose and up to 14 days post dose of IW-1973 | 
| Apparent Volume of Distribution (Vz/F) of IW-1973 |  | Predose and up to 14 days post dose of IW-1973 |