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Trials / Completed

CompletedNCT03499106

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Cyclerion Therapeutics · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGIW-1973Oral Tablet
DRUGItraconazoleOral Capsule

Timeline

Start date
2018-04-12
Primary completion
2018-07-06
Completion
2018-07-06
First posted
2018-04-17
Last updated
2019-04-03

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03499106. Inclusion in this directory is not an endorsement.

A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-197 (NCT03499106) · Clinical Trials Directory