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

• Status: Completed
• Trial end date: 2018-07-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cyclerion Therapeutics; Ironwood Pharmaceuticals, Inc.
• Treatments: Hydroxyitraconazole; Itraconazole; Praliciguat

Criteria

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