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

NCT06299709 | Completed Phase 1 FDA Drug

• 1 other identifier: VX23-121-012
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA

  Pre-dose up to 288 hours Post-dose

• Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA

  Pre-dose up to 384 hours Post-dose

• Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA

  Pre-dose up to 288 hours Post-dose

• Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA

  Pre-dose up to 384 hours Post-dose

Secondary Outcomes (2)

• Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to Day 42

• Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to Day 36

Study Arms (5)

Part A: Sequence 1

EXPERIMENTAL

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.

Drug: VNZ/TEZ/D-IVA

Part A: Sequence 2

EXPERIMENTAL

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.

Drug: VNZ/TEZ/D-IVA

Part A: Sequence 3

EXPERIMENTAL

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.

Drug: VNZ/TEZ/D-IVA

Part B: Sequence 1

EXPERIMENTAL

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.

Drug: VNZ/TEZ/D-IVA

Part B: Sequence 2

EXPERIMENTAL

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.

Drug: VNZ/TEZ/D-IVA

Interventions

VNZ/TEZ/D-IVA DRUG

FDC tablet for oral administration.

Also known as: VX-121/VX-661/CTP-656, VX-121/VX-661/VX-561, Vanzacaftor/tezacaftor/deutivacaftor

Part A: Sequence 1; Part A: Sequence 2; Part A: Sequence 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

deutivacaftor, tezacaftor , vanzacaftor

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 8, 2024
• Study Start: March 13, 2024
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)