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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03499106

Run by

Cyclerion Therapeutics

People needed

24

Starts

2018-04-12

Expected to finish

2018-07-06

Last updated by the study team

2019-04-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Any active or unstable clinically significant medical condition
• Use of any prescribed or non-prescribed medication
• Other exclusion criteria per protocol

Where it is running

• IQVIA — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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