Status:
COMPLETED
Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740
Lead Sponsor:
Cardurion Pharmaceuticals, Inc.
Conditions:
Clinical Pharmacology
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05437094
Start Date
June 27 2022
End Date
August 10 2022
Last Update
May 15 2025
Active Locations (1)
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1
Cardurion Investigative Site
Dallas, Texas, United States, 75247