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

NCT05437094 | Completed Phase 1 FDA Drug

• 1 other identifier: CRD-740-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• AUC0-24 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

• Cmax of CRD-740 alone and with coadministration of itraconazole

  Day 1 to Day 16

Secondary Outcomes (4)

• Half life (t1/2) of CRD-740

  Day 1 to Day 16

• Time to maximum concentration (Tmax) 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

Study Arms (2)

CRD-740

OTHER

CRD-740 single dose administered alone

Drug: CRD-740

CRD-740 and Itraconazole

OTHER

CRD-740 single dose administered with Itraconazole

Drug: CRD-740; Drug: Itraconazole

Interventions

CRD-740 DRUG

CRD-740

CRD-740; CRD-740 and Itraconazole

Itraconazole DRUG

Itraconazole

CRD-740 and Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardurion Pharmaceuticals, Inc.: lead

Study Sites (1)

Cardurion Investigative Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Heart Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 29, 2022
• Study Start: June 27, 2022
• Primary Completion: August 3, 2022
• Study Completion: August 10, 2022
• Last Updated: May 15, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)