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Hemoglobin S Polymerization Inhibitor

GBT021601 for Sickle Cell Disease

Phase 1

Waitlist Available

Research Sponsored by Global Blood Therapeutics

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 119 days from screening part a, 134 days from screening part b

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in people with sickle cell disease.

Eligible Conditions

Sickle Cell Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 119 days from screening part a, 134 days from screening part b

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~119 days from screening part a, 134 days from screening part b

This trial's timeline: 3 weeks for screening, Varies for treatment, and 119 days from screening part a, 134 days from screening part b for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plasma concentration

Safety, as assessed by changes in Blood pressure

Safety, as assessed by changes in Heart Rate.

+3 more

Secondary outcome measures

Determine plasma concentration of GBT021601.

Determine whole blood concentration of GBT021601

Safety, as assessed by changes in QTcF

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GBT021601Experimental Treatment1 Intervention

GBT021601 as a tablet or capsule with dose based off of preceding cohort's data.

Group II: PlaceboPlacebo Group1 Intervention

Placebo as a tablet or capsule with dose based off of preceding cohort's data.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GBT021601

2021

Completed Phase 1

~150

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Global Blood TherapeuticsLead Sponsor

35 Previous Clinical Trials

4,748 Total Patients Enrolled

PfizerLead Sponsor

4,575 Previous Clinical Trials

10,922,972 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,482 Previous Clinical Trials

8,099,234 Total Patients Enrolled

Frequently Asked Questions

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

What type of participants are ideal for this research endeavor?

"The requisite criteria to join this clinical trial is anemia, sickle cell and being between 18-55 years old. A total of 124 participants are needed for the study."

Answered by AI

Has the Food and Drug Administration granted approval for GBT021601?

"The safety of GBT021601 has been assessed to be a 1, given that this is only the first phase of trials and limited results exist regarding its efficacy."

Answered by AI

Does this research have any age restrictions?

"This research trial is seeking participants aged 18 to 55. There are a total of 131 studies involving minors, and 86 that focus on seniors."

Answered by AI

What is the total enrolment for this clinical trial?

"Affirmative, the details on clinicaltrials.gov demonstrate that this research project is currently recruiting participants. This endeavor was initially posted in December 9th 2020 and underwent a recent update August 15th 2022. The trial will be enrolling up to 124 patients at 1 location."

Answered by AI

Is the enrollment period still open for this research endeavor?

"According to the documentation on clinicaltrials.gov, this trial is actively recruiting volunteers and has been since December 9th 2020. It was last updated as recently as August 15th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants

2020. "A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036512.