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CFTR Modulator
Elexacaftor/Tezacaftor/Ivacaftor + Rifabutin for Drug Interaction
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 22 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24h area-under the plasma concentration time curve (AUC) of ELX/TEZ/IVA in the absence and the presence of concomitant rifabutin
Secondary outcome measures
Maximum plasma concentration (Cmax) of ELX/TEZ/IVA in the absence and the presence of concomitant rifabutin
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]
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
915 Previous Clinical Trials
1,603,700 Total Patients Enrolled
Adupa P Rao, M.D.Study DirectorKeck Medicine of USC
1 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that could affect how my body absorbs medication.I am currently breastfeeding.You have a history of uveitis (eye inflammation) or currently have eye or vision problems, except if you wear glasses or contact lenses.My kidney function is reduced.I have liver problems or a history of liver disease.I am a woman who can have children and my pregnancy test was positive.I am between 18 and 65 years old.I am not taking any medications that affect liver enzymes.I have not donated blood (about 1 pint) in the last 56 days.I am willing to stop taking herbal products like grapefruit and St. John's Wort 2 weeks before and during the study.I am using or will use effective birth control or am post-menopausal.I have not had major surgery in the last 4 weeks.You are allergic to rifamycins.
Research Study Groups:
This trial has the following groups:- Group 1: rifabutin
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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