drugset / Trial / NCT05981365

Voxelotor CYP and Transporter Cocktail Interaction Study

NCT05981365 ↗

Phase 1 Completed 44 enrolled Pfizer
Non-randomizedParallel-groupOpen-labelBasic science

Summary

This research study is examining multiple doses of voxelotor (a study drug intended for treatment of sickle cell disease) and how it interacts with additional substrates (substrates are drugs or other substances that are metabolized by cytochrome enzymes. The substrates used in this study are FDA approved medications). The study will help to determine the safety and tolerability of the study drugs taken together, as well as the pharmacokinetics (PK) on how your body processes and responds to the combination of the study drug and substrates. Although these drugs are FDA approved, their use in this study is experimental.

Timeline

Start
2023-04-17
Primary completion
2023-10-04
Completion
2023-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule — —
Subject Flurbiprofen Small molecule — —
Subject Furosemide Other / unclassified — —
Subject Metformin Small molecule — —
Subject Midazolam Small molecule — —
Subject Omeprazole Other / unclassified — —
Subject Repaglinide Small molecule — —
Subject Rosuvastatin Small molecule — —
Subject Voxelotor Small molecule — —

Indications