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CFTR Modulator

Elexacaftor/Tezacaftor/Ivacaftor + Rifabutin for Drug Interaction

Phase 4
Waitlist Available
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants between 18 and 65 years of age inclusive
Be older than 18 years old
Must not have
Any condition that could affect drug absorption (eg, gastrectomy, pancreatitis)
Female subjects who are breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study how the antibiotic rifabutin affects the way the body processes Trikafta, a medication used to treat cystic fibrosis.

Who is the study for?
Healthy adults aged 18-65 with a BMI of 17.5 to 30.5 kg/m2 and weight over 50kg can join this trial. They must not have significant medical history, be willing to avoid certain natural products, use reliable birth control, and not have conditions affecting drug absorption or major organ issues.
What is being tested?
The study is examining how Rifabutin affects the body's handling of Trikafta (a combination medication for cystic fibrosis). Participants will take both drugs in a controlled environment to see if there are any changes in how Trikafta works.
What are the potential side effects?
Possible side effects may include those commonly associated with antibiotics like Rifabutin such as nausea, rash or liver issues; and for Trikafta they might experience chest tightness, stomach discomfort or abnormal liver tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that could affect how my body absorbs medication.
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I am currently breastfeeding.
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My kidney function is reduced.
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I have liver problems or a history of liver disease.
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I am a woman who can have children and my pregnancy test was positive.
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I am not taking any medications that affect liver enzymes.
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I have not had major surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
24h area-under the plasma concentration time curve (AUC) of ELX/TEZ/IVA in the absence and the presence of concomitant rifabutin
Secondary study objectives
Maximum plasma concentration (Cmax) of ELX/TEZ/IVA in the absence and the presence of concomitant rifabutin

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: rifabutinExperimental Treatment2 Interventions
Rifabutin PO \[two 150mg capsules\] ; Trikafta PO \[one orange tablet containing ELX 100mg, TEZ 50mg, and IVA 75mg\]
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trikafta [orange tablet containing ELX 100mg, TEZ 50mg, and IVA 75mg]
2022
Completed Phase 4
~10
Rifabutin 300mg
2022
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,639 Total Patients Enrolled
Adupa P Rao, M.D.Study DirectorKeck Medicine of USC
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Trikafta (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04840862 — Phase 4
Drug Interaction Research Study Groups: rifabutin
Drug Interaction Clinical Trial 2023: Trikafta Highlights & Side Effects. Trial Name: NCT04840862 — Phase 4
Trikafta (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04840862 — Phase 4
~2 spots leftby Nov 2025
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