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
NCT ID: NCT03892499
Last Updated: 2019-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2019-05-03
2019-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Healthy Volunteers
Period 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose.
Olinciguat
Oral Tablet
Itraconazole
Oral Capsule
Interventions
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Olinciguat
Oral Tablet
Itraconazole
Oral Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Use of any prescribed or non-prescribed medication (except for hormonal birth control)
18 Years
55 Years
ALL
Yes
Sponsors
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Cyclerion Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Bina Tejura, MD
Role: STUDY_DIRECTOR
Cyclerion Therapeutics
Locations
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PPD
Austin, Texas, United States
Countries
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Other Identifiers
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OLI-105
Identifier Type: -
Identifier Source: org_study_id
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