Healthy AdultsPhase 1NCT06495944
Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants
A Phase 1 study testing Dazucorilant and Itraconazole in people with Healthy Adults, run by Corcept Therapeutics at 1 site in United States.
Trial summary
This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of dazucorilant in healthy adults. Participants in this study will complete screening assessments within 28 days before the first dose of study drug. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Dazucorilant and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 2 Aug 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be capable of and willing to comply with study restrictions and procedures
- Female participants must be non-nursing, have a negative pregnancy test result at screening and Day -1, and be surgically sterile for at least 90 days prior to screening or postmenopausal
- Male participants with female partners of child bearing potential must agree to use 2 acceptable forms of birth control for the duration of the study and for 90 days following the last administration of the drug; all male participants must refrain from donating sperm for this same period
- Be considered healthy by the Investigator, based on participant's reported medical history, full physical examination, clinical laboratory tests, 12-lead electrocardiograms (ECG) and vital signs
- Have normal renal function as determined by Investigator
- Have a body mass index (BMI) of 18.0 to 30.0 kg/m^2 inclusive and body weight >50.0 kg at screening
- Have no relevant dietary restrictions
- Be willing to comply with COVID-19 policy
Who cannot join
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, renal, hepatic, bronchopulmonary, psychiatric, neurologic, immunologic or lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator
- Known or suspected malignancy
- History of pancreatitis or gall stones
- History of unexplained syncope, symptomatic hypotension, or hypoglycemia
- Personal or family history of long QTc syndrome; QTcF >450 ms
- History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance
Show all 26Show fewer
- Gastrointestinal, liver, kidney disease, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion within 3 months prior to the screening and during the screening period
- Hypersensitivity to dazucorilant or itraconazole or any components of either formulation
- Poor venous access
- Positive blood screen for infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Donated or lost ≥500 mL of blood in the previous 60 days
- Plasma donation within 30 days prior to the 1st dose of study medication
- Taken an investigational drug or participated in a clinical trial within 90 days (or 5 half-lives), whichever is longer, prior to the 1st dose of study medication
- Used prescription or over-the-counter (OTC) medication (other than ≤1 g/day acetaminophen), antacids, vitamins or herbal remedies or supplements, within 2 weeks or 5 half-lives before first study drug administration, whichever is longer
- Used food or drugs that are inducers of CYP3A4/5 and/or P-glycoprotein inducers within 30 days prior to the first dose of study medication
- Consumption of grapefruit, pomelo, or Seville oranges or their juices or jams, from 30 days prior to Day -1
- Hospital admission or major surgery within 6 months prior to screening or a preplanned hospital admission during study participation
- A history of prescription drug abuse or illicit drug use within 12 months prior to screening
- Use of cannabis or cannabidiol (CBD) containing products within 30 days prior to study drug administration on Day 1
- A history of alcohol abuse according to medical history within 2 years prior to screening
- Use of tobacco- or nicotine-containing products or participants unwilling/unable to stop nicotine intake from 6 months prior to screening until the end of the study
- A positive screen for alcohol, drugs of abuse, or cotinine at screening or Day -1
- An unwillingness or inability to comply with food and beverage restrictions during study participation
- Investigational site staff members directly involved in the conduct of the study and their family members; site staff members otherwise supervised by the Investigator or Corcept Therapeutics Incorporated employees directly involved in the conduct of the study
- Any condition or finding that in the Investigator's opinion would put the participant or study conduct at risk if the participant were to participate in the study
- Unable to complete this study for other reasons or the Investigator believes that he or she should be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Characterize the Impact of the Cytochrome P450 3A Inhibitor Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Subjects
This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of dazucorilant in healthy adults.
Participants in this study will complete screening assessments within 28 days before the first dose of study drug. Those participants who can participate will be admitted to the clinical pharmacology center (CPC) and complete pretreatment tests. Those participants will stay at the CPC for the duration of the study. On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, after eating. On Days 5-11, all participants will receive once daily, oral doses of itraconazole 200 mg, after eating. Blood and safety assessments will continue for 96-hours after dosing on Day 1 and Day 8. Participants will leave the CPC following completion of all procedures on Day 12.
Participants will return to the CPC for a final visit 7 (±1) days after their final dose of study medication.
- Conditions
- Healthy Adults
- Being tested
- Dazucorilant, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DazucorilantDrug
Also called CORT113176
75 mg soft gelatin capsules formulation for oral administration
ItraconazoleDrug
100 mg capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dazucorilant (300 mg) and itraconazole (200 mg) | Experimental | On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, in a fed state. On Days 5-11, all participants will be administered once daily, oral doses of itraconazole 200 mg, in a fed state. Receives: Drug: Dazucorilant; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of dazucorilant
Measured: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8
Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) of plasma dazucorilant
Measured: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of plasma dazucorilant
Measured: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8
Secondary outcomes (5)
Number of Participants with 1 or More Adverse Events
Measured: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal ECG Result
Measured: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Vital Signs
Measured: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Physical Examination Finding
Measured: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Clinical Laboratory Test Result
Measured: Up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start31 May 2024
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Custodio, PhD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495944
- Sponsor's protocol ID
- CORT113176-655
- Status last verified
- Jun 2025
- First submitted
- 3 Jul 2024
- Last updated
- 1 Jul 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Characterize the Impact of the Cytochrome P450 3A Inhibitor Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Subjects
- ClinicalTrials.gov ID
- NCT06495944
- Acronym / sponsor ID
- CORT113176-655
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 May 2024 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 11 Jul 2024 (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 study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of dazucorilant in healthy adults.
Participants in this study will complete screening assessments within 28 days before the first dose of study drug. Those participants who can participate will be admitted to the clinical pharmacology center (CPC) and complete pretreatment tests. Those participants will stay at the CPC for the duration of the study. On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, after eating. On Days 5-11, all participants will receive once daily, oral doses of itraconazole 200 mg, after eating. Blood and safety assessments will continue for 96-hours after dosing on Day 1 and Day 8. Participants will leave the CPC following completion of all procedures on Day 12.
Participants will return to the CPC for a final visit 7 (±1) days after their final dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dazucorilant (300 mg) and itraconazole (200 mg) | Experimental | Drug: Dazucorilant, Drug: ItraconazoleOn Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, in a fed state. On Days 5-11, all participants will be administered once daily, oral doses of itraconazole 200 mg, in a fed state. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be capable of and willing to comply with study restrictions and procedures
- Female participants must be non-nursing, have a negative pregnancy test result at screening and Day -1, and be surgically sterile for at least 90 days prior to screening or postmenopausal
- Male participants with female partners of child bearing potential must agree to use 2 acceptable forms of birth control for the duration of the study and for 90 days following the last administration of the drug; all male participants must refrain from donating sperm for this same period
- Be considered healthy by the Investigator, based on participant's reported medical history, full physical examination, clinical laboratory tests, 12-lead electrocardiograms (ECG) and vital signs
- Have normal renal function as determined by Investigator
Key exclusion criteria (26 listed)
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, renal, hepatic, bronchopulmonary, psychiatric, neurologic, immunologic or lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator
- Known or suspected malignancy
- History of pancreatitis or gall stones
- History of unexplained syncope, symptomatic hypotension, or hypoglycemia
- Personal or family history of long QTc syndrome; QTcF >450 ms
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 |
|---|---|---|
| DazucorilantAlso: CORT11317675 mg soft gelatin capsules formulation for oral administration | Drug | Dazucorilant (300 mg) and itraconazole (200 mg) |
| Itraconazole100 mg capsules for oral administration | Drug | Dazucorilant (300 mg) and itraconazole (200 mg) |
Primary outcome
Maximum observed plasma concentration (Cmax) of dazucorilant
Time frame: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8
Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) of plasma dazucorilant
Time frame: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of plasma dazucorilant
Time frame: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8
5 secondary outcomes
Number of Participants with 1 or More Adverse Events
Time frame: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal ECG Result
Time frame: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Vital Signs
Time frame: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Physical Examination Finding
Time frame: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Clinical Laboratory Test Result
Time frame: Up to Day 18
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 1 Jul 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.
Joseph Custodio, PhD study director
Corcept Therapeutics
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 Dazucorilant and Itraconazole in people with Healthy Adults, run by Corcept Therapeutics 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 8 inclusion and 26 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 1 Jul 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?
Maximum observed plasma concentration (Cmax) of dazucorilant (time frame: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8). The study lists 3 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 1 Jul 2025.