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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03499106

Enrollment

Registered

2018-04-17

Start date

2018-04-12

Completion date

2018-07-06

Last updated

2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGIW-1973

Oral Tablet

DRUGItraconazole

Oral Capsule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
Time to Cmax (Tmax) 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
Apparent Terminal Rate Constant (lambda[z]) 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026