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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 day 7
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of GSK4172239D in SCD patients.
Who is the study for?
Adults aged 18-50 with Sickle Cell Disease (SCD), not on gamma-globin increasing meds, weighing over 50 kg, and able to consent. Men must practice abstinence or use contraception; women must be non-childbearing. Excludes those with certain blood counts, drug abuse history, significant heart disease, organ disorders affecting drug metabolism, abnormal blood pressure or kidney function, recent transfusions or certain medications.Check my eligibility
What is being tested?
The trial is testing GSK4172239D's safety and how the body processes it compared to a placebo in people with SCD. It involves three phases: screening, treatment where participants are randomly given either the study drug or placebo in varying doses including under fed conditions for some after a break period.See study design
What are the potential side effects?
Specific side effects aren't listed but generally could include reactions related to the body's processing of GSK4172239D versus placebo. Safety and tolerability will be closely monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under curve zero to time infinity (AUC 0-inf) for GSK4106401 after a single oral dose of GSK4172239D
Half-life (t1/2) for GSK4106401 after a single oral dose of GSK4172239D
Maximum observed plasma concentration (Cmax) for GSK4106401 after a single oral dose of GSK4172239D
+3 moreSecondary outcome measures
Number of participants with adverse event (AE) and serious adverse event (SAE)
Number of participants with clinically significant change from baseline in 12 lead electrocardiograms (ECG)
Number of participants with clinically significant change from baseline in vital signs
+7 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Food effect cohortExperimental Treatment2 Interventions
One selected cohort will also receive an additional single dose of GSK4172239D (or matching placebo) under fed (high calorie and high fat) conditions.
Group II: Cohort 5Experimental Treatment2 Interventions
Participants in this arm will receive either single dose of GSK4172239D (Dose 5) or matching placebo.
Group III: Cohort 4Experimental Treatment2 Interventions
Participants in this arm will receive either single dose of GSK4172239D (Dose 4) or matching placebo.
Group IV: Cohort 3Experimental Treatment2 Interventions
Participants in this arm will receive either single dose of GSK4172239D (Dose 3) or matching placebo.
Group V: Cohort 2Experimental Treatment2 Interventions
Participants in this arm will receive either single dose of GSK4172239D (Dose 2) or matching placebo.
Group VI: Cohort 1Experimental Treatment2 Interventions
Participants in this arm will receive either single dose of GSK4172239D (Dose 1) or matching placebo.
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,795 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,900 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any drugs or supplements that could affect the study in the last 7 to 14 days, except for low-dose acetaminophen.I have not used hydroxyurea or decitabine in the last 9 weeks.I have a history of serious heart problems.I do not have any major health issues that could affect how my body handles medication.I only use drugs for medical reasons, like pain or anxiety, as prescribed by my doctor.I have not had a blood transfusion in the last 3 months.I have SCD and am not on medication that increases fetal hemoglobin.I have sickle cell disease and previous treatments didn't work for me.My weight is over 50 kilograms.I understand the study and can agree to participate.I tested positive for drugs or alcohol, but I use opioids for pain or benzodiazepines for anxiety as prescribed.I am a male and will not donate sperm. I will either abstain from sex or use reliable birth control methods.I am a woman who cannot become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 2
- Group 3: Cohort 5
- Group 4: Cohort 1
- Group 5: Food effect cohort
- Group 6: Cohort 4
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Cohort 5 received governmental authorization from the FDA?
"Cohort 5 is rated a 1 on our scale due to the fact that this Phase 1 trial has only limited evidence backing its safety and efficacy."
Answered by AI
Are there still opportunities for people to take part in this trial?
"Clinicaltrials.gov verifies that recruitment for this medical trial is no longer underway, as the posting was initially published on February 3rd 2023 and last updated January 23rd 2023. Nevertheless, there are a plethora of other trials currently admitting patients to participate."
Answered by AI
What are the qualifications necessary to partake in this medical experiment?
"This medical trial is recruiting 40 individuals with a blood disorder, aged 18 to 50. To be eligible, they must have a body weight of more than 50 kilograms and meet other requirements including the inability to give birth (for female participants) and refraining from donating sperm or using contraception while engaging in intercourse with women of childbearing potential (for male participants). Furthermore, those who are taking medication which increases gamma-globin and failed or not tolerated approved therapies for SCD may also qualify."
Answered by AI
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