NCT07349394

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

A Phase 1, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Doses of Vanzacaftor/Tezacaftor/Deutivacaftor on the Pharmacokinetics of Rosuvastatin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is being conducted to evaluate the effect of multiple doses of VNZ/TEZ/D-IVA on the PK of rosuvastatin and the safety and tolerability of coadministration of VNZ/TEZ/D-IVA with rosuvastatin in healthy participants. Note: 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 CFR11.60and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24and11.44.).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VNZ/TEZ/D-IVA	Fixed-dose combination (FDC) Tablet for oral administration.
DRUG	Rosuvastatin	Tablet for oral administration.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-02-28
• Completion: 2026-03-12
• First posted: 2026-01-16
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study