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

Cyclerion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Itraconazole; Drug: IW-1973

Study type: Interventional

Funder types: Industry

Identifiers

NCT03499106

C1973-104

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Healthy Volunteers

Experimental group

Description:

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.

Treatment:

Drug: Itraconazole

Drug: IW-1973