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Voxelotor CYP and Transporter Cocktail Interaction Study

NCT05981365 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-11-22

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2023-10-04
Completion
2023-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981365 on ClinicalTrials.gov