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

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ClinicalTrials.gov Identifier: NCT03499106
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: IW-1973 Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual 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 IW-1973
Actual Study Start Date : April 12, 2018
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : July 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Volunteers
Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose.
Drug: IW-1973
Oral Tablet

Drug: Itraconazole
Oral Capsule




Primary Outcome Measures :
  1. Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf]) [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]
  2. Maximum Observed Plasma Concentration (Cmax) of IW-1973 [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]

Secondary Outcome Measures :
  1. Time to Cmax (Tmax) of IW-1973 [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]
  2. Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973 [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]
  3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973 [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]
  4. Apparent Terminal Half-Life (t1/2) of IW-1973 [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]
  5. Apparent Terminal Rate Constant (lambda[z]) of IW-1973 [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]
  6. Apparent Total Plasma Clearance (CL/F) of IW-1973 [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]
  7. Apparent Volume of Distribution (Vz/F) of IW-1973 [ Time Frame: Predose and up to 14 days post dose of IW-1973 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is an ambulatory adult between 18 and 75 years old at the screening visit
  • Subject is in good health and has no clinically significant findings on physical examination
  • Body mass index is > 18 and < 30.0 kg/m2 at the screening visit
  • Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 2 months after the final dose of study drug
  • Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 2 months after the final dose of study drug
  • Other inclusion criteria per protocol

Exclusion Criteria:

  • Any active or unstable clinically significant medical condition
  • Use of any prescribed or non-prescribed medication
  • 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): NCT03499106


Locations
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United States, Kansas
IQVIA
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Cyclerion Therapeutics

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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT03499106     History of Changes
Other Study ID Numbers: C1973-104
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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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