Celerion, Inc.
Tempe, Arizona, 85283, United States
NCT Number: NCT06299709
The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
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 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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.
FDC tablet for oral administration.
Other names: VX-121/VX-661/CTP-656, VX-121/VX-661/VX-561, Vanzacaftor/tezacaftor/deutivacaftor
Time frame: Pre-dose up to 288 hours Post-dose
Time frame: Pre-dose up to 384 hours Post-dose
Time frame: Pre-dose up to 288 hours Post-dose
Time frame: Pre-dose up to 384 hours Post-dose
Time frame: Day 1 up to Day 42
Time frame: Day 1 up to Day 36
Vertex Pharmaceuticals Incorporated
Industry
A Phase 1, Randomized, Open-Label, 2-part Study to Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor in Combination With Tezacaftor and Deutivacaftor in Healthy Adult Subjects
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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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