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

Vertex Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Cystic Fibrosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07349394

VX25-121-014

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 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

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

VNZ/TEZ/D-IVA and Rosuvastatin

Experimental group

Description:

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.

Treatment:

Drug: VNZ/TEZ/D-IVA

Drug: Rosuvastatin