Clinical trial NCT05437094: Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Pharmacology
Pharmacokinetics
Cardiovascular Diseases
Heart Failure
Lead sponsor: Cardurion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: AUC0-24 of CRD-740 alone and with coadministration of itraconazole
timeFrame: Day 1 to Day 16
measure: AUC0-inf of CRD-740 alone and with coadministration of itraconazole
timeFrame: Day 1 to Day 16
measure: AUC0-t of CRD-740 alone and with coadministration of itraconazole
timeFrame: Day 1 to Day 16
measure: Cmax of CRD-740 alone and with coadministration of itraconazole
timeFrame: Day 1 to Day 16
Secondary outcomes:
measure: Half life (t1/2) of CRD-740
timeFrame: Day 1 to Day 16
measure: Time to maximum concentration (Tmax) of CRD-740
timeFrame: Day 1 to Day 16
measure: Oral clearance (CL/F) of CRD-740
timeFrame: Day 1 to Day 16
measure: Apparent volume of distribution during terminal phase (Vz/F) of CRD-740
timeFrame: Day 1 to Day 16
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Cardurion Investigative Site
state: Texas
Study officials:
References: