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

Phase 1

Completed

• Conditions: Pharmacokinetics; Cardiovascular Diseases; Clinical Pharmacology; Heart Failure
• Interventions: Drug: CRD-740; Drug: Itraconazole

• Registration Number: NCT05437094
• Lead Sponsor: Cardurion Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-23
• Study Start: 2022-06-27
• Study First Posted: 2022-06-29
• Primary Completion: 2022-08-03
• Study Completion: 2022-08-10
• Status Verified: 2023-02
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CRD-740 and Itraconazole	CRD-740	CRD-740 single dose administered with Itraconazole
CRD-740	CRD-740	CRD-740 single dose administered alone
CRD-740 and Itraconazole	Itraconazole	CRD-740 single dose administered with Itraconazole

Primary Outcome Measures

Name	Time	Method
AUC0-24 of CRD-740 alone and with coadministration of itraconazole	Day 1 to Day 16
Cmax of CRD-740 alone and with coadministration of itraconazole	Day 1 to Day 16
AUC0-inf of CRD-740 alone and with coadministration of itraconazole	Day 1 to Day 16
AUC0-t of CRD-740 alone and with coadministration of itraconazole	Day 1 to Day 16

Secondary Outcome Measures

Name	Time	Method
Time to maximum concentration (Tmax) of CRD-740	Day 1 to Day 16
Half life (t1/2) of CRD-740	Day 1 to Day 16
Oral clearance (CL/F) of CRD-740	Day 1 to Day 16
Apparent volume of distribution during terminal phase (Vz/F) of CRD-740	Day 1 to Day 16

Trial Locations

Locations (1)

Cardurion Investigative Site; 🇺🇸 Dallas, Texas, United States