CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
Voxelotor +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05981365
NCT05981365Phase 1Completed

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

Pfizer·interventional·Posted Aug 8, 2023·Updated Nov 22, 2024

In Brief

A Phase 1 clinical trial evaluating Voxelotor, Bupropion, and 7 other interventions for Sickle Cell Disease. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedAug 8, 2023
Enrollment StartApr 17, 2023
Primary CompletionOct 4, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.9 years ago

Interventions

Voxelotordrug

Drug drug interaction

Bupropiondrug

Drug drug interaction

Repaglinidedrug

Drug drug interaction

Flurbiprofendrug

Drug drug interaction

Omeprazoledrug

Drug drug interaction

Midazolamdrug

Drug drug interaction

Metformindrug

Drug drug interaction

Furosemidedrug

Drug drug interaction

Rosuvastatindrug

Drug drug interaction