Itraconazole + Dazucorilant for Drug Interaction Study

Overseen By Corcept Therapeutics

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Corcept Therapeutics

Must not be taking: CYP3A4/5 inducers

Disqualifiers: Gastrointestinal, Cardiovascular, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the interaction between two drugs, itraconazole and dazucorilant, in healthy adults. Researchers aim to determine how these drugs affect each other in the body and assess their safety and tolerability when taken together. Participants will take dazucorilant on specific days and itraconazole daily for part of the study, with regular health check-ups. This study suits healthy individuals without major health issues, allergies to the drugs, or recent use of other medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical research.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking most prescription and over-the-counter medications, as well as vitamins and supplements, at least two weeks before the study starts. You also cannot use certain foods or drugs that affect liver enzymes within 30 days before the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that dazucorilant is safe and well-tolerated in people. In earlier studies, participants took dazucorilant without major problems. Researchers are now testing dazucorilant with itraconazole to evaluate their combined effects. Itraconazole is already used for other health issues and is known to be safe.

Some individuals taking itraconazole have experienced interactions with other medications, but careful monitoring helps manage these risks. So far, the combination of dazucorilant and itraconazole has been well-tolerated, suggesting that it may be safe for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about dazucorilant because it offers a unique approach to treatment by potentially reducing inflammation and stress hormone levels, which are often involved in various conditions, including depression and stress-related disorders. Unlike standard treatments that focus mainly on neurotransmitter levels, dazucorilant works by targeting the glucocorticoid receptor pathway, which is a novel mechanism of action. This could provide a new avenue for addressing conditions that current medications may not fully alleviate, potentially offering faster and more effective relief.

What evidence suggests that this trial's treatments could be effective?

This trial will examine the interaction between dazucorilant and itraconazole. Research has shown that dazucorilant can improve memory in animals with Alzheimer's disease, suggesting potential benefits for people with similar conditions. It blocks certain stress-related hormones, which may enhance brain function. Itraconazole influences drug metabolism and is frequently used to study drug interactions. While limited information exists on the interaction between dazucorilant and itraconazole in humans, itraconazole's role in such studies is well-established. This trial investigates how these drugs interact, which is crucial for understanding their effects and safety. ^{1 2 4 5 6}

Who Is on the Research Team?

Joseph Custodio, PhD

Principal Investigator

Corcept Therapeutics

Are You a Good Fit for This Trial?

Healthy adults who pass medical exams, have no dietary restrictions, agree to COVID-19 policies, and follow study rules can join. Women must be non-nursing or postmenopausal; men with partners must use birth control. Participants need normal kidney function and a BMI of 18.0-30.0 kg/m2.

Inclusion Criteria

I am willing to follow COVID-19 safety guidelines.

I have no dietary restrictions.

I am willing and able to follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single oral dose of dazucorilant on Days 1 and 8, and daily doses of itraconazole from Days 5-11

12 days

Continuous stay at CPC

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dazucorilant
• Itraconazole

Trial Overview The trial tests how itraconazole affects the body's handling and safety of dazucorilant when taken by healthy adults. Participants will stay at a center for the study duration, taking both drugs orally after meals and undergoing regular blood and safety checks.

How Is the Trial Designed?

Group I: Dazucorilant (300 mg) and itraconazole (200 mg) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06495944?term=corcept&rank=7

Impact of Itraconazole on the Pharmacokinetics and Safety ... This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06495944/impact-of-itraconazole-on-the-pharmacokinetics-and-safety-of-dazucorilant-in-healthy-adult-participants

Impact of Itraconazole on the Pharmacokinetics and Safety ... This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ...

3. synapse.patsnap.com synapse.patsnap.com/drug/f6310048c9f349a481e5439a8d515520

Dazucorilant - Drug Targets, Indications, Patents Key Results: In both AD models, chronic treatment with dazucorilant improved working and long‐term spatial memories along with the inhibition of glucocorticoid ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3250854/

Itraconazole: Precautions regarding drug interactions and ... Four patients responded despite decreased itraconazole levels, although two had a worsening of seborrheic dermatitis; one patient had worsening cryptococcal ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31215774/

Recommendations for the Design of Clinical Drug ... Regulatory agencies currently recommend itraconazole (ITZ) as a strong cytochrome P450 3A (CYP3A) inhibitor for clinical drug-drug interaction (DDI) studies.

6. finance.yahoo.com finance.yahoo.com/news/corcept-therapeutics-advances-pipeline-fueling-135815118.html

Corcept Therapeutics Advances Pipeline Fueling Growth ... The findings are expected to optimize drug interaction safety. Additionally, after gaining positive results from the Phase 3 ROSELLA trial ...