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NCT06299709Recruiting

A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

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
Vertex Pharmaceuticals IncorporatedPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Cystic Fibrosis
Drug/Device/Intervention
VNZ/TEZ/D-IVA
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Vertex Pharmaceuticals Incorporated
Location
Tempe, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Mar 13, 2024
End date
Jun 01, 2024
Enrollment
34 participants
Primary outcome

Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA,Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA,Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA,Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA

Summary

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.

ICD-10 classifications
Cystic fibrosisCystic fibrosis, unspecifiedCystic fibrosis with other manifestationsCystic fibrosis with pulmonary manifestationsCystic fibrosis with intestinal manifestations
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06299709
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06299709 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vertex Pharmaceuticals Incorporated and is currently Recruiting. The study focuses on Cystic Fibrosis. Target enrollment is 34 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.