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NOT YET RECRUITING
NCT07389525
EARLY_PHASE1

Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

Immune checkpoint inhibitors (ICIs) (also called "immunotherapy") are an effective family of anti-cancer drugs, but they can cause serious side effects. Some evidence suggests these side effects might happen because ICIs interact with other drugs that you may already be taking, making those drugs work differently, or causing more side effects. The purpose of this study is to see whether ICIs impact how the liver processes other drugs. To do this, participants will be given a probe cocktail of 7 different FDA-approved drugs that are processed in different ways in the liver.

Official title: Assessment of Drug-Drug Interactions Between Immune Checkpoint Inhibitors and Cytochrome P450 Substrates: Immune Checkpoint Inhibitor (ICI)-Drug-Drug Interaction (DDI) Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-03

Completion Date

2027-12

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

ICI Therapy

Low dose of a cocktail of probe substrates for eight major CYP enzymes/drug transporters.

Locations (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States