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Completed

NCT Number: NCT05437094

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cardurion Investigative Site

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRD-740

Drug

CRD-740

Itraconazole

Drug

Itraconazole

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cardurion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2022
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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