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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

NCT03892499 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-07-15

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Olinciguat

Oral Tablet

DRUG

Itraconazole

Oral Capsule

Sponsors & Collaborators

  • Cyclerion Therapeutics

    lead INDUSTRY

Principal Investigators

  • Bina Tejura, MD · Cyclerion Therapeutics

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2019-06-23
Completion
2019-07-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892499 on ClinicalTrials.gov