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

Completed · Phase 1

Conditions studied: Clinical Pharmacology, Pharmacokinetics, Cardiovascular Diseases, Heart Failure

In brief

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.

Key facts

Study ID

NCT05437094

Run by

Cardurion Pharmaceuticals, Inc.

People needed

20

Starts

2022-06-27

Expected to finish

2022-08-10

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Significant medical history as determined by the investigator.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including itraconazole, unless approved by the investigator (or designee).
• 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).
• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator.
• History or presence of an abnormal ECG.
• 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).
• 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.
• 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.
• Ingestion of poppy seed, Seville orange, or grapefruit containing foods or beverages within 7 days prior to check-in.

Where it is running

• Cardurion Investigative Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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