Clincosm LogoSign in Get a demo

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

Sponsor
Cyclerion Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03892499
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
2
Actual Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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)
Actual Study Start Date :
May 3, 2019
Actual Primary Completion Date :
Jun 23, 2019
Actual Study Completion Date :
Jul 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Olinciguat
Oral Tablet
Other Names:
  • IW-1701

    • Drug: Itraconazole
    Oral Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of olinciguat [Predose and up to 8 days post first olinciguat dose]

    2. Area under the plasma concentration time curve from time zero (predose) extrapolated to infinity (AUCinf) [Predose and up to 8 days post first olinciguat dose]

    Secondary Outcome Measures

    1. Number of subjects with ≥1 treatment-emergent adverse event (TEAE) in Period 1 vs Period 2 [51 days post first olinciguat dose]

    2. Cmax of Itraconazole [First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)]

    3. Area under the concentration-time curve during a dosing interval (AUCtau) for itraconazole and hydroxy-itraconazole [Period 2 (Period 2 duration can be up to 13 days) predose and up to 24 hour after 2nd olinciguat dose]

    4. Cmax of hydroxy-Itraconazole [First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PPD Austin Texas United States 78744

    Sponsors and Collaborators

    • Cyclerion Therapeutics

    Investigators

    • Study Director: Bina Tejura, MD, Cyclerion Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cyclerion Therapeutics
    ClinicalTrials.gov Identifier:
    NCT03892499
    Other Study ID Numbers:
    • OLI-105
    First Posted:
    Mar 27, 2019
    Last Update Posted:
    Jul 15, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Itraconazole

    Study Results

    No Results Posted as of Jul 15, 2019