Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants

NCT07349394 | Completed Phase 1 FDA Drug

• 1 other identifier: VX25-121-014
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of multiple doses of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) on the PK of rosuvastatin and the safety and tolerability of coadministration of VNZ/TEZ/D-IVA with rosuvastatin.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Concentration (Cmax) of Rosuvastatin in the Absence and Presence of VNZ/TEZ/D-IVA

  Day 1 up to Day 23

• Area Under the Concentration Time-curve (AUC) of Rosuvastatin in the Absence and Presence of VNZ/TEZ/D-IVA

  Day 1 up to Day 23

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 39

Study Arms (1)

VNZ/TEZ/D-IVA and Rosuvastatin

EXPERIMENTAL

Rosuvastatin will be administered to participants as a single oral dose on Day 1 and then co-administered with VNZ/TEZ/D-IVA on Day 18.VNZ/TEZ/D-IVA dose will be administered once daily (qd) from Day 5 to Day 22.

Drug: VNZ/TEZ/D-IVA; Drug: Rosuvastatin

Interventions

VNZ/TEZ/D-IVA DRUG

Fixed-dose combination (FDC) Tablet for oral administration.

Also known as: Vanzacaftor/Tezacaftor/Deutivacaftor, VX-121/VX-661/VX-561, VX-121/VX-661/CTP-656

VNZ/TEZ/D-IVA and Rosuvastatin

Rosuvastatin DRUG

Tablet for oral administration.

VNZ/TEZ/D-IVA and Rosuvastatin

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 within 5 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)

Altasciences - Kansas City

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

deutivacaftor, tezacaftor , vanzacaftor; Rosuvastatin Calcium

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: January 12, 2026
• Primary Completion: February 28, 2026
• Study Completion: March 12, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)