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

Cystic Fibrosis Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, 2-part Study to Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor in Combination With Tezacaftor and Deutivacaftor in Healthy Adult Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06299709
• Other study ID #: VX23-121-012
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 13, 2024
• Est. completion date: June 2024

Study information

• Verified date: June 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• VNZ/TEZ/D-IVA
FDC tablet for oral administration.
• VNZ/TEZ/D-IVA
FDC granules for oral administration.

Locations

Country	Name	City	State
United States	Celerion, Inc.	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA		Pre-dose up to 288 hours Post-dose
Primary	Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA		Pre-dose up to 384 hours Post-dose
Primary	Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA		Pre-dose up to 288 hours Post-dose
Primary	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	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
Secondary	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