Altasciences - Kansas City
Overland Park, Kansas, 66212, United States
NCT Number: NCT07349394
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Overland Park, Kansas, 66212, United States
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.).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Fixed-dose combination (FDC) Tablet for oral administration.
Other names: Vanzacaftor/Tezacaftor/Deutivacaftor, VX-121/VX-661/VX-561, VX-121/VX-661/CTP-656
Tablet for oral administration.
Time frame: Day 1 up to Day 23
Time frame: Day 1 up to Day 23
Time frame: Day 1 up to Day 39
Vertex Pharmaceuticals Incorporated
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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