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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT03892499

Run by

Cyclerion Therapeutics

People needed

24

Starts

2019-05-03

Expected to finish

2019-07-03

Last updated by the study team

2019-07-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PPD — Austin, Texas, United States

Full record on ClinicalTrials.gov

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