Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2023-03-16

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.

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Detailed Description

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This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1: Moderate Hepatic Impairment

Participants with moderate hepatic impairment will receive single dose of VX-121/TEZ/D-IVA .

Group Type EXPERIMENTAL

VX-121/TEZ/D-IVA

Intervention Type DRUG

Fixed-dose combination tablets for oral administration.

Cohort 2: Matched Healthy Participants

Healthy participants will receive single dose of VX-121/TEZ/D-IVA.

Group Type EXPERIMENTAL

VX-121/TEZ/D-IVA

Intervention Type DRUG

Fixed-dose combination tablets for oral administration.

Interventions

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VX-121/TEZ/D-IVA

Fixed-dose combination tablets for oral administration.

Intervention Type DRUG

Other Intervention Names

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VX-121/VX-661/VX-561 VX-121/VX-661/CTP-656 VX-121/tezacaftor/deutivacaftor

Eligibility Criteria

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Inclusion Criteria

* Cohort 1: Participants with Moderate Hepatic Impairment

* Participants will satisfy the criteria for moderate hepatic impairment defined as a Child-Pugh total score of 7 to 9 points at the screening visit
* Participants will have chronic (≥6 months) documented liver disease
* Cohort 2: Matched Healthy Participants

* Participants will be matched during screening to participants with hepatic impairment for cigarette smoking habit, age, sex, and weight

Exclusion Criteria

* Cohort 1: Participants with Moderate Hepatic Impairment

* History of febrile illness or other acute illness
* History of solid organ or bone marrow transplantation
* History or presence of severe hepatic encephalopathy (Grade \>2)
* Any condition possibly affecting drug absorption
* Severe portal hypertension
* Significant renal dysfunction (creatinine clearance \<50 milliliter per minute \[mL/min\] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1
* Cohort 2: Matched Healthy Participants

* History of febrile illness or other acute illness
* Any condition possibly affecting drug absorption

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes