Clinical PharmacologyPhase 1NCT05437094
Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740
A Phase 1 study testing CRD-740 and Itraconazole in people with Clinical Pharmacology and Pharmacokinetics, run by Cardurion Pharmaceuticals, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology, Pharmacokinetics, Cardiovascular Diseases
- What is being tested?
- CRD-740 and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2022to 10 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- CRD-740, Itraconazole
- Medical subject headings
- Cardiovascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD-740Drug
CRD-740
ItraconazoleDrug
Itraconazole
| Study group | Role | What they receive |
|---|---|---|
| CRD-740 | Other | CRD-740 single dose administered alone Receives: Drug: CRD-740 |
| CRD-740 and Itraconazole | Other | CRD-740 single dose administered with Itraconazole Receives: Drug: CRD-740; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24 of CRD-740 alone and with coadministration of itraconazole
Measured: Day 1 to Day 16
AUC0-inf of CRD-740 alone and with coadministration of itraconazole
Measured: Day 1 to Day 16
AUC0-t of CRD-740 alone and with coadministration of itraconazole
Measured: Day 1 to Day 16
Cmax of CRD-740 alone and with coadministration of itraconazole
Measured: Day 1 to Day 16
Secondary outcomes (4)
Half life (t1/2) of CRD-740
Measured: Day 1 to Day 16
Time to maximum concentration (Tmax) of CRD-740
Measured: Day 1 to Day 16
Oral clearance (CL/F) of CRD-740
Measured: Day 1 to Day 16
Apparent volume of distribution during terminal phase (Vz/F) of CRD-740
Measured: Day 1 to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start27 Jun 2022
- Primary completion3 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437094
- Sponsor's protocol ID
- CRD-740-101
- Status last verified
- Feb 2023
- First submitted
- 17 Jun 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05437094
- Acronym / sponsor ID
- CRD-740-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardurion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRD-740 | Other | Drug: CRD-740CRD-740 single dose administered alone |
| CRD-740 and Itraconazole | Other | Drug: CRD-740, Drug: ItraconazoleCRD-740 single dose administered with Itraconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRD-740CRD-740 | Drug | CRD-740, CRD-740 and Itraconazole |
| ItraconazoleItraconazole | Drug | CRD-740 and Itraconazole |
Primary outcome
AUC0-24 of CRD-740 alone and with coadministration of itraconazole
Time frame: Day 1 to Day 16
AUC0-inf of CRD-740 alone and with coadministration of itraconazole
Time frame: Day 1 to Day 16
AUC0-t of CRD-740 alone and with coadministration of itraconazole
Time frame: Day 1 to Day 16
Cmax of CRD-740 alone and with coadministration of itraconazole
Time frame: Day 1 to Day 16
4 secondary outcomes
Half life (t1/2) of CRD-740
Time frame: Day 1 to Day 16
Time to maximum concentration (Tmax) of CRD-740
Time frame: Day 1 to Day 16
Oral clearance (CL/F) of CRD-740
Time frame: Day 1 to Day 16
Apparent volume of distribution during terminal phase (Vz/F) of CRD-740
Time frame: Day 1 to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRD-740 and Itraconazole in people with Clinical Pharmacology and Pharmacokinetics, run by Cardurion Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-24 of CRD-740 alone and with coadministration of itraconazole (time frame: Day 1 to Day 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.