What side effects are associated with this type of intervention?

Common treatments involving CYP3A4 inhibition, such as Itraconazole, often result in side effects like increased levels of certain drugs in the body due to reduced metabolism. Specific side effects observed with Itraconazole include headaches and elevated liver enzymes. Additionally, when combined with other medications, Itraconazole can significantly alter their pharmacokinetics, leading to increased or decreased drug concentrations, which may enhance or reduce their efficacy and toxicity.

What prior FDA approvals exist?

Itraconazole is an antifungal agent known for its role as a potent inhibitor of the CYP3A4 enzyme. While itraconazole itself is not typically used in healthy subjects, it is often studied for its effects on the pharmacokinetics of other drugs metabolized by CYP3A4. The FDA has approved itraconazole for the treatment of fungal infections, and its inhibitory effects on CYP3A4 are leveraged in clinical pharmacology studies to understand drug interactions. Other drugs that inhibit CYP3A4 and have been approved by the FDA include ketoconazole and fluconazole, which are also primarily used to treat fungal infections but are studied for their interaction potential in healthy subjects.

What other types of research exist?

Promising novel alternatives to Itraconazole for CYP3A4 inhibition in healthy subjects include Posaconazole and Voriconazole. Both are newer antifungal agents with strong CYP3A4 inhibitory effects and have been shown to be effective in clinical settings. Additionally, newer agents like Isavuconazole are being explored for their potential benefits and may offer improved safety profiles.

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Itraconazole Effect on S-309309 in Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Shionogi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how taking itraconazole affects the way the body handles another drug, S-309309. Researchers want to understand if itraconazole changes how much of S-309309 gets into the bloodstream and how long it stays there. Itraconazole is an orally active antifungal agent that has complex and highly variable absorption.

Who is the study for?

This trial is for medically healthy adults with a BMI of 18.5 to 30.0 kg/m^2 who can follow the study's procedures and agree to use contraception according to local guidelines. People with significant past surgeries or current major health issues, severe drug allergies, or heart problems cannot participate.

What is being tested?

The study aims to see how taking Itraconazole affects the body's handling of a new drug called S-309309. Participants will receive S-309309 alone and combined with Itraconazole so researchers can compare the differences in drug levels in the body.

What are the potential side effects?

While specific side effects are not listed, common ones related to drugs like Itraconazole may include headache, stomach discomfort, dizziness, and rash. The new drug S-309309 might have unknown side effects that will be monitored during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: S-309309Experimental Treatment2 Interventions

All participants will receive each of the following treatments: * Days 1 and 19: S-309309 once daily (QD); in the fasted state) * Day 15: Itraconazole twice daily (BID); in the fed state) * Days 16 to 24: Itraconazole QD (in the fed state, except for Day 19 \[co-administration with S-309309 in the fasted state\])

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

S309309

2023

Completed Phase 1

~20

Itraconazole

2017

Completed Phase 2

~830

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Itraconazole works by inhibiting the enzyme CYP3A4, which is responsible for metabolizing many drugs in the liver. This inhibition can lead to increased levels of drugs that are CYP3A4 substrates, potentially enhancing their effects or causing toxicity. For healthy subjects, understanding this interaction is important to avoid adverse effects and ensure the safe and effective use of medications that are metabolized by CYP3A4.

[New recommendations in oncocardiology].Inference of synergy/antagonism between anticancer drugs from the pooled analysis of clinical trials.[Chemotherapy in soft tissue sarcomas].