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Impact of Rifabutin on the Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor

NCT04840862 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-08-09

No results posted yet for this study

Summary

This is a prospective, single-center, fixed-sequence, nonrandomized, open-label study in healthy adults to investigate the impact of rifabutin on the pharmacokinetics of trikafta.

Conditions

  • Drug Drug Interaction

Interventions

DRUG

Trikafta [orange tablet containing ELX 100mg, TEZ 50mg, and IVA 75mg]

Subjects will receive a single dose of trikafta (orange tablet) on day 1 of period 1 and on day 15 of period 2.

DRUG

Rifabutin 300mg

After washout period greater or equal to 2 days, subjects will receive 300 mg/d of rifabutin on days 1 through 17 of period 2.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Adupa P Rao, M.D. · Keck Medicine of USC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2024-05-30
Completion
2024-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840862 on ClinicalTrials.gov