NCT05981365

Voxelotor CYP and Transporter Cocktail Interaction Study

A Phase 1, Open-Label, Two-Part, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Voxelotor on the Pharmacokinetics of Selected CYP and Transporter Probe Substrates in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label, fixed-sequence, 2-period evaluation study. This means the study doctor and participants in the study will know what study drugs they are taking. There will be approximately 46 healthy male and female participants between the ages of 18 - 55. There will be two parts of the study: parts A and B. Part A will consist of 26 healthy male and female participants (at least 20% African American). For Part A, participant involvement is expected to last approximately 81 days, including a 33-day screening period and a 48-day on study period (consisting of 2 study treatment periods, a washout period lasting 7 to 14 days, and the Follow-up visit). Part B will consist of 20 healthy male and female participants (at least 20% African American). For Part B, participant involvement is expected to last approximately 68 days, including a 33-day screening period and a 35-day on study period (consisting of 2 study treatment periods, a washout period lasting 7 to 14 days, and the Follow-up visit). You will only be allowed to be in one part of the study.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Voxelotor	Drug drug interaction
DRUG	Bupropion	Drug drug interaction
DRUG	Repaglinide	Drug drug interaction
DRUG	Flurbiprofen	Drug drug interaction
DRUG	Omeprazole	Drug drug interaction
DRUG	Midazolam	Drug drug interaction
DRUG	Metformin	Drug drug interaction
DRUG	Furosemide	Drug drug interaction
DRUG	Rosuvastatin	Drug drug interaction

Timeline

• Start date: 2023-04-17
• Primary completion: 2023-10-04
• Completion: 2023-10-04
• First posted: 2023-08-08
• Last updated: 2024-11-22
• Results posted: 2024-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study