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

C

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

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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