drugset / Trial / NCT06154447

Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis

NCT06154447 ↗

Phase 1 Active not recruiting 165 enrolled Vertex Pharmaceuticals Incorporated
RandomizedSequentialQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ)/ VX-118 or TEZ/ deutivacaftor (D-IVA) in healthy participants and VX-828 in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).

Timeline

Start
2023-12-12
Primary completion
2026-07-16
Completion
2026-07-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule — Oral
Subject Midazolam Small molecule — Oral
Subject VX-118 Unknown — Oral
Subject VX-828 Unknown — Oral
Subject deutivacaftor Unknown — Oral
Subject tezacaftor Other / unclassified — Oral

Indications