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Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740

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ClinicalTrials.gov Identifier: NCT05437094
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Cardurion Pharmaceuticals, Inc.

Brief Summary:
This is a Phase 1, single-site, open-label, fixed sequence crossover study to investigate the effect of coadministration of itraconazole on the pharmacokinetics of CRD-740 in healthy male and female subjects. Subjects will be admitted into the study site on Day -1 and will be confined to the study site until discharge on Day 16. Subjects will receive CRD-740 orally on Days 1 and 10. Itraconazole will be given once daily, orally, on Days 7 through 15.

Condition or disease Intervention/treatment Phase
Clinical Pharmacology Pharmacokinetics Cardiovascular Diseases Heart Failure Drug: CRD-740 Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Fixed Sequence Study to Investigate the Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740 in Healthy Adult Subjects
Actual Study Start Date : June 27, 2022
Estimated Primary Completion Date : August 10, 2022
Estimated Study Completion Date : August 17, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
CRD-740
CRD-740 single dose administered alone
Drug: CRD-740
CRD-740

CRD-740 and Itraconazole
CRD-740 single dose administered with Itraconazole
Drug: CRD-740
CRD-740

Drug: Itraconazole
Itraconazole




Primary Outcome Measures :
  1. AUC0-24 of CRD-740 alone and with coadministration of itraconazole [ Time Frame: Day 1 to Day 16 ]
  2. AUC0-inf of CRD-740 alone and with coadministration of itraconazole [ Time Frame: Day 1 to Day 16 ]
  3. AUC0-t of CRD-740 alone and with coadministration of itraconazole [ Time Frame: Day 1 to Day 16 ]
  4. Cmax of CRD-740 alone and with coadministration of itraconazole [ Time Frame: Day 1 to Day 16 ]

Secondary Outcome Measures :
  1. Half life (t1/2) of CRD-740 [ Time Frame: Day 1 to Day 16 ]
  2. Time to maximum concentration (Tmax) of CRD-740 [ Time Frame: Day 1 to Day 16 ]
  3. Oral clearance (CL/F) of CRD-740 [ Time Frame: Day 1 to Day 16 ]
  4. Apparent volume of distribution during terminal phase (Vz/F) of CRD-740 [ Time Frame: Day 1 to Day 16 ]


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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:

  1. Males or females, of any race, between 18 and 55 years of age, inclusive.
  2. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
  3. In good health, determined by no clinically significant findings as assessed by the investigator.
  4. Adhere to all contraception criteria.

Exclusion Criteria:

  1. Significant medical history as determined by the investigator.
  2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including itraconazole, unless approved by the investigator (or designee).
  3. History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
  4. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator.
  5. History or presence of an abnormal ECG.
  6. Use or intend to use any medications/products/herbal remedies known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
  7. Drugs affecting CYP3A4 should be refrained from use for 3 weeks, or 5 half-lives (whichever is longer), prior to check-in through to follow-up.
  8. Positive urine drug screen at screening or positive alcohol breath test result or positive urine drug screen at check-in.21. History of alcoholism or drug/chemical abuse within 12 months prior to check-in.
  9. Ingestion of poppy seed, Seville orange, or grapefruit containing foods or beverages within 7 days prior to check-in.

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): NCT05437094


Contacts
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Contact: Pirouz Shamszad, MD 617-863-8088 info@cardurion.com

Locations
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United States, Texas
Cardurion Investigative Site Recruiting
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Cardurion Pharmaceuticals, Inc.
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Responsible Party: Cardurion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05437094    
Other Study ID Numbers: CRD-740-101
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
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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Cardiovascular Diseases
Itraconazole
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