ClinicalTrials.gg
CompletedNCT05437094Updated May 15, 2025

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

A Phase 1 interventional study of CRD-740 and Itraconazole in Clinical Pharmacology, Pharmacokinetics and Cardiovascular Diseases, sponsored by Cardurion Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.

Primary conditionHeart FailureRegistry: Cardiovascular DiseasesReclassifiedWhy we changed it
Registry
Cardiovascular Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Heart Failure
Why
  1. The study's listed conditions name Heart Failure, a narrower term within Cardiovascular Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Cardurion Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2022, 4 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Clinical Pharmacology
  • Pharmacokinetics
  • Cardiovascular Diseases
  • Heart Failure

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03

In context

Heart Failure Reclassified

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's enrollment of 20 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Cardurion Pharmaceuticals, Inc. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Compared within Heart Failure, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males or females, of any race, between 18 and 55 years of age, inclusive.
  2. between 18.0 and 32.0 kg/m2, inclusive.
  3. In good health, determined by no findings as assessed by the investigator.
  4. Adhere to all criteria.

Exclusion criteria

Exclusion Criteria:

  1. Significant medical history as determined by the investigator.
  2. History of significant , 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 abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator.
  5. History or presence of an abnormal .
  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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    CRD-740

    CRD-740 single dose administered alone

    Drug: CRD-740

  • Other
    CRD-740 and Itraconazole

    CRD-740 single dose administered with Itraconazole

    Drug: CRD-740 · Drug: Itraconazole

Interventions

  • CRD-740

  • DrugItraconazole

    Itraconazole

06

What researchers measure

Primary outcomes

  1. AUC0-24 of CRD-740 alone and with coadministration of itraconazole

    Time frame: Day 1 to Day 16

  2. AUC0-inf of CRD-740 alone and with coadministration of itraconazole

    Time frame: Day 1 to Day 16

  3. AUC0-t of CRD-740 alone and with coadministration of itraconazole

    Time frame: Day 1 to Day 16

  4. Cmax of CRD-740 alone and with coadministration of itraconazole

    Time frame: Day 1 to Day 16

Secondary outcomes

  1. Half life (t1/2) of CRD-740

    Time frame: Day 1 to Day 16

  2. Time to maximum concentration (Tmax) of CRD-740

    Time frame: Day 1 to Day 16

  3. Oral clearance (CL/F) of CRD-740

    Time frame: Day 1 to Day 16

  4. Apparent volume of distribution during terminal phase (Vz/F) of CRD-740

    Time frame: Day 1 to Day 16

07

Study locations

1 site
  • Cardurion Investigative Site
    Dallas, Texas 75247, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Aug 2022, 1 month.

Of 76 industry-sponsored phase 1 interventional studies under Heart Failure, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 16. This study's 1 month is below that.

Counting every sponsor, half of 130 studies reached it within 14 months; a quarter within 4 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2022
First posted
Jun 29, 2022
StartActual
Jun 27, 2022
Primary completionActual
Aug 3, 2022
CompletionActual
Aug 10, 2022
Last update
May 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05437094
Lead sponsor
Cardurion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jun 29, 2022
Start date
Jun 27, 2022
Primary completion
Aug 3, 2022
Completion
Aug 10, 2022
Last update
May 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pf-04447943

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