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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05437094
• Other study ID #: CRD-740-101
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2022
• Est. completion date: August 10, 2022

Study information

• Verified date: February 2023
• Source: Cardurion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 10, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Clinical Pharmacology
• Heart Failure
• Pharmacokinetics

Intervention

Drug:
• CRD-740
CRD-740
• Itraconazole
Itraconazole

Locations

Country	Name	City	State
United States	Cardurion Investigative Site	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cardurion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-24 of CRD-740 alone and with coadministration of itraconazole		Day 1 to Day 16
Primary	AUC0-inf of CRD-740 alone and with coadministration of itraconazole		Day 1 to Day 16
Primary	AUC0-t of CRD-740 alone and with coadministration of itraconazole		Day 1 to Day 16
Primary	Cmax of CRD-740 alone and with coadministration of itraconazole		Day 1 to Day 16
Secondary	Half life (t1/2) of CRD-740		Day 1 to Day 16
Secondary	Time to maximum concentration (Tmax) of CRD-740		Day 1 to Day 16
Secondary	Oral clearance (CL/F) of CRD-740		Day 1 to Day 16
Secondary	Apparent volume of distribution during terminal phase (Vz/F) of CRD-740		Day 1 to Day 16