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

NCT ID: NCT05437094

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2022-08-10

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.

Conditions

Clinical Pharmacology; Pharmacokinetics; Cardiovascular Diseases; Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRD-740

CRD-740 single dose administered alone

Group Type: OTHER

CRD-740

Intervention Type: DRUG

CRD-740

CRD-740 and Itraconazole

CRD-740 single dose administered with Itraconazole

Group Type: OTHER

CRD-740

Intervention Type: DRUG

CRD-740

Itraconazole

Intervention Type: DRUG

Itraconazole

Interventions

CRD-740

CRD-740

Intervention Type: DRUG

Itraconazole

Itraconazole

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardurion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cardurion Investigative Site

Dallas, Texas, United States

Countries

United States

Other Identifiers

CRD-740-101

Identifier Type: -

Identifier Source: org_study_id