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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: VNZ/TEZ/D-IVA

Study type: Interventional

Funder types: Industry

Identifiers

NCT06299709

VX23-121-012

Details and patient eligibility

About

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.

Full description

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.).

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 5 patient groups

Part A: Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: VNZ/TEZ/D-IVA

Drug: VNZ/TEZ/D-IVA

Part A: Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: VNZ/TEZ/D-IVA

Drug: VNZ/TEZ/D-IVA

Part A: Sequence 3

Experimental group

Description:

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.

Treatment:

Drug: VNZ/TEZ/D-IVA

Drug: VNZ/TEZ/D-IVA

Part B: Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: VNZ/TEZ/D-IVA

Drug: VNZ/TEZ/D-IVA

Part B: Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: VNZ/TEZ/D-IVA

Drug: VNZ/TEZ/D-IVA