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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

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ClinicalTrials.gov Identifier: NCT03892499
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

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
Healthy Drug: Olinciguat Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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)
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: IW-1701

Drug: Itraconazole
Oral Capsule




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of olinciguat [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 51 days post first olinciguat dose ]
  2. Cmax of Itraconazole [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days) ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892499


Contacts
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Contact: Kyle Herbert 978.995.4951 Kherbert@cyclerion.com

Locations
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United States, Texas
PPD Recruiting
Austin, Texas, United States, 78744
Contact: Study Coordinator         
Sponsors and Collaborators
Cyclerion Therapeutics
Investigators
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Study Director: Bina Tejura, MD Cyclerion Therapeutics

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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT03892499     History of Changes
Other Study ID Numbers: OLI-105
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors