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

• Status: Completed
• Trial end date: 2019-07-03
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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