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

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.

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