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Dazucorilant

Dazucorilant, also known as CORT113176, is a drug currently being investigated in clinical trials for its potential benefits in treating Amyotrophic Lateral Sclerosis (ALS) and its pharmacokinetic properties. This article explores two ongoing studies: one examining the drug’s interaction with itraconazole in healthy adults, and another evaluating its safety and efficacy in patients with ALS. These trials aim to provide valuable insights into Dazucorilant’s potential as a treatment option and its behavior in the human body.

Table of Contents

What is Dazucorilant?

Dazucorilant, also known by its research code CORT113176, is a new drug currently being studied for its potential to treat various medical conditions[1]. It is administered orally in the form of soft gelatin capsules, making it convenient for patients to take[2].

What Conditions Does Dazucorilant Treat?

The primary condition being investigated for treatment with Dazucorilant is Amyotrophic Lateral Sclerosis (ALS)[2]. ALS, also known as Lou Gehrig’s disease, is a progressive neurological disease that causes the neurons responsible for controlling voluntary muscle movement to degenerate and die. This leads to muscle weakness, paralysis, and eventually affects a person’s ability to speak, eat, and breathe.

Additionally, the drug is being studied in healthy adults, which suggests that researchers are exploring its potential uses in other medical conditions or as a preventive treatment[1].

How Does Dazucorilant Work?

While the exact mechanism of action is not fully described in the provided information, we can infer some details based on the clinical trials. Dazucorilant appears to interact with an enzyme system in the body called Cytochrome P450 3A[1]. This enzyme system is involved in the metabolism of many drugs and other substances in the body. By interacting with this system, Dazucorilant may affect how the body processes certain chemicals or medications, which could be beneficial in treating ALS or other conditions.

Current Clinical Trials

There are currently two main clinical trials involving Dazucorilant:

  1. Drug Interaction Study in Healthy Adults: This study aims to understand how Dazucorilant interacts with another drug called itraconazole (an antifungal medication) in healthy adult participants. The researchers are looking at how itraconazole affects the way the body processes Dazucorilant[1].

  2. Phase 2 Study in ALS Patients: This is a larger study testing the safety and effectiveness of Dazucorilant in patients with ALS. The study is comparing two different doses of Dazucorilant (150 mg and 300 mg) against a placebo to see if it can help slow the progression of ALS symptoms[2].

Dosage and Administration

In the clinical trials, Dazucorilant is being tested at different dosages:

  • 300 mg once daily[2]
  • 150 mg once daily[2]

The medication is taken orally in the form of soft gelatin capsules. Each capsule contains 75 mg of Dazucorilant, so patients may need to take multiple capsules to reach their prescribed dose[1][2].

Safety and Side Effects

As Dazucorilant is still in the clinical trial phase, comprehensive information about its safety profile and side effects is not yet available. However, the ongoing studies are closely monitoring several safety aspects, including:

  • Adverse events (side effects)
  • Serious adverse events
  • Changes in ECG results (a test that checks heart function)
  • Changes in vital signs
  • Abnormal physical examination findings
  • Changes in clinical laboratory test results[1]

These safety measures will help researchers understand the potential risks and side effects associated with Dazucorilant use.

Future Research and Potential

The ongoing clinical trials for Dazucorilant are promising, especially for patients with ALS. If successful, this drug could potentially help slow the progression of ALS symptoms and improve patients’ quality of life. The ALS study is measuring several important outcomes, including:

  • Changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score, which measures the progression of disability in ALS patients
  • Changes in muscle strength
  • Changes in breathing capacity (measured by slow vital capacity)
  • Changes in quality of life (measured by the EuroQol-5 Dimensions-5 Levels questionnaire)[2]

Additionally, the drug interaction study with itraconazole suggests that researchers are investigating how Dazucorilant might interact with other medications. This information will be crucial for understanding how to safely use Dazucorilant in patients who may be taking multiple medications[1].

As research progresses, we may learn more about Dazucorilant’s potential uses in other conditions beyond ALS. The involvement of healthy adults in one of the studies suggests that researchers are exploring its broader applications and safety profile[1].

Aspect Drug Interaction Study ALS Clinical Trial
Study Type Open-label, single-sequence crossover Phase 2, randomized, double-blind, placebo-controlled
Participants Healthy adults Patients with ALS
Dazucorilant Dose 300 mg single dose 150 mg or 300 mg daily
Duration 12 days + follow-up visit 24 weeks + potential 132-week extension
Primary Outcomes Pharmacokinetic parameters (Cmax, AUClast, AUCinf) Change in ALSFRS-R score, Adverse events
Secondary Outcomes Adverse events, ECG, vital signs, physical exam, lab tests Muscle strength, vital capacity, quality of life

FAQ

  • What is Dazucorilant? Dazucorilant, also known as CORT113176, is a drug currently being studied in clinical trials. It is being investigated for its potential benefits in treating Amyotrophic Lateral Sclerosis (ALS) and its pharmacokinetic properties when interacting with other medications.
  • What is the purpose of the drug interaction study with itraconazole? The drug interaction study aims to understand how repeat doses of itraconazole (an antifungal medication) affect the pharmacokinetics, safety, and tolerability of single doses of Dazucorilant in healthy adults. This information is important to understand how Dazucorilant may interact with other medications.
  • What is the main goal of the ALS clinical trial for Dazucorilant? The main goal of the ALS clinical trial is to assess the safety and efficacy of Dazucorilant in patients with Amyotrophic Lateral Sclerosis (ALS). The study will evaluate different doses of the drug compared to a placebo over a 24-week period.
  • How is Dazucorilant administered in these trials? In both trials, Dazucorilant is administered orally. In the ALS study, it is given as softgel capsules, with doses of either 150 mg or 300 mg once daily. In the drug interaction study, a single 300 mg dose is given on specific days.
  • What are some of the outcomes being measured in these trials? In the ALS trial, key outcomes include changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) score, muscle strength, vital capacity, and quality of life. The drug interaction study focuses on measuring the concentration of Dazucorilant in the blood and monitoring for any adverse events.

Ongoing Clinical Trials on Dazucorilant

  • Study on the Safety and Effectiveness of Dazucorilant for Patients with Amyotrophic Lateral Sclerosis (ALS)

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Ireland The Netherlands Poland +1

Glossary

  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Amyotrophic Lateral Sclerosis (ALS): A progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control.
  • Itraconazole: An antifungal medication used to treat various fungal infections.
  • Cytochrome P450 3A: An enzyme in the liver that helps break down many medications. Itraconazole inhibits this enzyme, which can affect how other drugs are processed in the body.
  • Open-Label Study: A type of clinical trial where both the researchers and participants know which treatment is being given.
  • Double-Blind Study: A type of clinical trial where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs.
  • ALS Functional Rating Scale-Revised (ALSFRS-R): A questionnaire-based scale used to measure the functional status of ALS patients.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • Vital Capacity: The maximum amount of air a person can expel from the lungs after a maximum inhalation, often used to assess respiratory function in ALS patients.
  • EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): A standardized instrument used to measure health-related quality of life.

References