Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants
NCT ID: NCT07349394
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2026-01-12
2026-04-04
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VNZ/TEZ/D-IVA and Rosuvastatin
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.
VNZ/TEZ/D-IVA
Fixed-dose combination (FDC) Tablet for oral administration.
Rosuvastatin
Tablet for oral administration.
Interventions
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VNZ/TEZ/D-IVA
Fixed-dose combination (FDC) Tablet for oral administration.
Rosuvastatin
Tablet for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A total body weight greater than (\>)50 kg
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Altasciences - Kansas City
Overland Park, Kansas, United States
Countries
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Central Contacts
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Other Identifiers
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VX25-121-014
Identifier Type: -
Identifier Source: org_study_id
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