A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of the Soluble Guanylate Cyclase Stimulator, Olinciguat (IW-1701), in Healthy Volunteers

Cyclerion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Olinciguat; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03892499

OLI-105

Details and patient eligibility

About

To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics (PK) of olinciguat

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is an ambulatory adult and between 18 and 55 years old (inclusive) 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 kg/m2 at the screening visit
• Women of reproductive potential must have a negative pregnancy test at screening at at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and until 90 days after receiving the final study drug dose
• Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and until 90 days after receiving the final study drug dose
• Other inclusion criteria per protocol

Exclusion criteria

• Any active or unstable clinically significant medical condition
• Use of any prescribed or non-prescribed medication (except for hormonal birth control)
• 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 olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose.

Treatment:

Drug: Itraconazole

Drug: Olinciguat