NCT03892499

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

An Open-label, 2-Period, Fixed-sequence, Phase 1 Study in Healthy Volunteers to Evaluate the Effect of Itraconazole, a Potent CYP3A Inhibitor, on the Pharmacokinetics of Olinciguat (IW-1701)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cyclerion Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Olinciguat	Oral Tablet
DRUG	Itraconazole	Oral Capsule

Timeline

• Start date: 2019-05-03
• Primary completion: 2019-06-23
• Completion: 2019-07-03
• First posted: 2019-03-27
• Last updated: 2019-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study