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Part A for Sickle Cell Disease

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 81 days
Awards & highlights

Study Summary

This trial looks at the safety & tolerability of combining a study drug for sickle cell disease with other FDA approved medications. It'll assess how your body processes & responds to the combination. Use of the drugs in this study is experimental.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 81 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 81 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A- Maximum observed plasma concentration (Cmax) for bupropion
Part A- Maximum observed plasma concentration (Cmax) for flurbiprofen
Part A- Maximum observed plasma concentration (Cmax) for midazolam
+21 more
Secondary outcome measures
Part A- Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Part A- Incidence of clinically significant changes in clinical laboratory tests, physical examination findings, and vital signs
Part A- Maximum observed plasma concentration (Cmax) for 1-hydroxymidazolam
+35 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment4 Interventions
To evaluate the effect of multiple doses of voxelotor on the plasma PK of a single dose of metformin, furosemide, and rosuvastatin
Group II: Part AExperimental Treatment6 Interventions
To evaluate the effect of multiple doses of voxelotor on the plasma pharmacokinetics (PK) of a single dose of bupropion, repaglinide, flurbiprofen, omeprazole, and midazolam
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupropion
2011
Completed Phase 4
~3310
Midazolam
2018
Completed Phase 4
~1910
Repaglinide
2016
Completed Phase 4
~7040
Metformin
2006
Completed Phase 4
~2430
Flurbiprofen
2022
Completed Phase 4
~870
Furosemide
2015
Completed Phase 4
~4240
Voxelotor
2023
Completed Phase 4
~90
Rosuvastatin
2019
Completed Phase 4
~3150
Omeprazole
2006
Completed Phase 4
~940

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,568 Previous Clinical Trials
10,911,842 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,093,010 Total Patients Enrolled

Media Library

Voxelotor (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05981365 — Phase 1
Sickle Cell Disease Research Study Groups: Part A, Part B
Sickle Cell Disease Clinical Trial 2023: Voxelotor Highlights & Side Effects. Trial Name: NCT05981365 — Phase 1
Voxelotor (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05981365 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial permit applicants over 30 years of age?

"This clinical trial is open to enrollees aged 18 years or older and younger than 55."

Answered by AI

Does Part A have the sanction of the FDA?

"Our team at Power rated the safety of Part A a 1 given that this is an early-stage trial with limited data supporting its efficacy and security."

Answered by AI

Who is eligible to participate in this clinical investigation?

"This clinical trial is looking to include up to 46 individuals with sickle cell disease in the age range of 18-55."

Answered by AI

What is the maximum capacity of participants for this clinical trial?

"Affirmative. On clinicaltrials.gov, the information indicates that this experiment is actively seeking participants; it was first posted on April 17th 2023 and updated most recently in July 31st of the same year. Currently, 46 individuals are needed from one medical centre to complete enrollment requirements for the trial."

Answered by AI

Are there still vacancies in this research trial?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this research study, which was initially published on April 17th 2023, is actively recruiting patients. 46 individuals are sought to be enrolled from one medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Voxelotor CYP and Transporter Cocktail Interaction Study
2023. "Voxelotor CYP and Transporter Cocktail Interaction Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05981365.
~22 spots leftby Apr 2025
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