A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor

NCT05535959 | Completed Phase 1 FDA Drug

• 1 other identifier: VX22-121-009
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA).

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of VX-121, TEZ, and D-IVA

  Pre-dose up to 288 hours Post-dose

• Area Under the Concentration Versus Time Curve (AUC) of VX-121, TEZ, and D-IVA

  Pre-dose up to 288 hours Post-dose

Secondary Outcomes (1)

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

  Day 1 up to Day 28

Study Arms (2)

Sequence 1

EXPERIMENTAL

Participants will receive a single dose of reference FDC tablet of VX-121/TEZ/D-IVA in dosing period 1, followed by a single dose of test FDC tablet of VX-121/TEZ/D-IVA in dosing period 2. A washout period of 14 days will be maintained between the 2 dosing periods.

Drug: VX-121/TEZ/D-IVA

Sequence 2

EXPERIMENTAL

Participants will receive a single dose of test FDC tablet of VX-121/TEZ/D-IVA in dosing period 1, followed by a single dose of reference FDC tablet of VX-121/TEZ/D-IVA in dosing period 2. A washout period of 14 days will be maintained between the 2 dosing periods.

Drug: VX-121/TEZ/D-IVA

Interventions

VX-121/TEZ/D-IVA DRUG

FDC tablet for oral administration.

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

Sequence 1; Sequence 2

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 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
• History of cardiovascular disease or central nervous system disease

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

ICON Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

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: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 15, 2022
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)