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GSK2256098 500 MBq

Phase 1

Hypertension, Pulmonary | Small molecule | Cardiovascular |GSK plc|Last Updated: Nov 14, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

GSK2256098 500 MBq · 1 trial · 1 indication

Phase 1 1
NCT02551653Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) PatientsHypertension, Pulmonary
COMPLETED10 Analytics
PHASE1COMPLETED
Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients
Hypertension, PulmonaryUnlock trial analytics

Study Endpoints

Primary Endpoints

Volume of Distribution of Radiolabeled GSK2256098 Measured by PET Scan
Day 1

The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the volume of distribution (VT). The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.

Standardized Uptake Values (SUV) of Radiolabeled GSK2256098 Measured by PET Scan
Day 1

The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the mean standardized uptake value (SUV) averaged over the 60 minute period between 30 and 90 minutes. The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
[11C]-GSK2256098EXPERIMENTALSubjects will receive single IV bolus injection of \[11C\]-GSK2256098 over about 30 seconds. Each unit dose will contain up to 500 millibecquerel (MBq) of \[11C\]-GSK2256098 with maximum \[11C\]-GSK2256098 mass \<=10 microgram (mcg).

Interventions

NameTypeDescription
[11C]-GSK2256098 500 MBqDRUG\[11C\]-GSK2256098 injection will be provided as IV infusion, 20 mL, containing up to 5% ethanol in saline.
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Eligibility Criteria

Age Range40 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Inclusion criteria for healthy volunteers \- Healthy subjects enrolled between 40 to 70 years inclusive at the time of signing the informed consent. Healthy subjects will be recruited to be age (+/-5 years) and gender matched to idiopathic PAH patients. * Healthy as determined...

Countries:United Kingdom
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Frequently asked questions about GSK2256098 500 MBq

What is GSK2256098 500 MBq used for?

GSK2256098 500 MBq is an investigational small molecule being studied for use in pulmonary hypertension, a type of high blood pressure affecting the lungs. It is currently in Phase 1 clinical development, meaning it is still being tested in early-stage trials and is not yet approved for any medical use.

What does GSK2256098 500 MBq target?

GSK2256098 500 MBq is a small molecule being developed by GSK plc. The specific molecular target of this drug has not been disclosed in the available information, so its mechanism of action is not described here.

Who makes GSK2256098 500 MBq?

GSK2256098 500 MBq is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded on the stock market under the ticker symbol GSK.

What phase is GSK2256098 500 MBq in?

GSK2256098 500 MBq is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing early-stage clinical trials to evaluate its safety and behavior in the body.

What clinical trials is GSK2256098 500 MBq in?

GSK2256098 500 MBq has one completed Phase 1 clinical trial registered under NCT02551653. This study, conducted in the United Kingdom, evaluated the biodistribution of [11C]-GSK2256098 in healthy subjects and patients with idiopathic pulmonary arterial hypertension. The trial enrolled 10 participants.

Is GSK2256098 500 MBq the same as [11C]-GSK2256098?

Yes, GSK2256098 500 MBq is the same drug as [11C]-GSK2256098. The clinical trial NCT02551653 used the radiolabeled form [11C]-GSK2256098 to study the drug's distribution in the body, and GSK2256098 500 MBq refers to the same investigational compound.