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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Heart Failure; Pharmacokinetics; Clinical Pharmacology
• Intervention / Treatment: Drug: CRD-740; Drug: Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pirouz Shamszad, MD; Phone Number: 617-863-8088; Email: info@cardurion.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Cardurion Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: CRD-740; CRD-740 single dose administered alone	Drug: CRD-740; CRD-740
OTHER: CRD-740 and Itraconazole; CRD-740 single dose administered with Itraconazole	Drug: CRD-740; CRD-740; Drug: Itraconazole; Itraconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Cardurion Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 27, 2022
• Primary Completion (ACTUAL): August 3, 2022
• Study Completion (ACTUAL): August 10, 2022

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (ACTUAL): June 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: CRD-740-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No