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A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

NCT ID: NCT06299709

Last Updated: 2025-09-26

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2024-05-23

Brief Summary

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The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.

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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

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Sequence 1

Participants will receive VNZ/TEZ/D-IVA reference fixed dose combination (FDC) tablet in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC tablet for oral administration.

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC granules for oral administration.

Part A: Sequence 2

Participants will receive VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 2, and finally VNZ/TEZ/D-IVA reference FDC tablet in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC tablet for oral administration.

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC granules for oral administration.

Part A: Sequence 3

Participants will receive VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 1, then VNZ/TEZ/D-IVA reference FDC tablet in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.

Group Type EXPERIMENTAL

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC tablet for oral administration.

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC granules for oral administration.

Part B: Sequence 1

Participants will receive VNZ/TEZ/D-IVA test FDC granules under fasted condition in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules under fed state in dosing period 2. A washout period of 18 days will be maintained between 2 dosing periods.

Group Type EXPERIMENTAL

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC granules for oral administration.

Part B: Sequence 2

Participants will receive VNZ/TEZ/D-IVA test FDC granules under fed state in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules under fasted condition in dosing period 2. A washout period of 18 days will be maintained between 2 dosing periods.

Group Type EXPERIMENTAL

VNZ/TEZ/D-IVA

Intervention Type DRUG

FDC granules for oral administration.

Interventions

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VNZ/TEZ/D-IVA

FDC tablet for oral administration.

Intervention Type DRUG

VNZ/TEZ/D-IVA

FDC granules for oral administration.

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
* A total body weight greater than (\>)50 kg

Exclusion Criteria

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
* Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion, Inc.

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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VX23-121-012

Identifier Type: -

Identifier Source: org_study_id

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