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

Cardurion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Clinical Pharmacology; Cardiovascular Diseases; Heart Failure; Pharmacokinetics

Treatments: Drug: Itraconazole; Drug: CRD-740

Study type: Interventional

Funder types: Industry

Identifiers

NCT05437094

CRD-740-101

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CRD-740

Other group

Description:

CRD-740 single dose administered alone

Treatment:

Drug: CRD-740

CRD-740 and Itraconazole

Other group

Description:

CRD-740 single dose administered with Itraconazole

Treatment:

Drug: CRD-740

Drug: Itraconazole