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GSK2212836

Phase 1

Cardiovascular Disease | Small molecule | Cardiovascular |GSK plc|Last Updated: Jun 22, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

GSK2212836 · 1 trial · 1 indication

Phase 1 1
NCT00996268An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836.Cardiovascular Disease
COMPLETED46 Analytics
PHASE1COMPLETED
An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836.
Cardiovascular DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: To determine the total (AUC(0 to infinity)) and peak (Cmax) exposure of GSK2212836
24 hours
Part B: PK parameters AUC(0-24h) and Cmax following 14 days of dosing with GSK2212836
14 days
Part A: To assess the relative bioavailability of GSK2212836 test capsules vs the reference formulation GSK2213836
24 hours
Part B: To estimate the accumulation and dose proportionality of GSK2212836 after repeat dosing of the test formulation
14 days

Secondary Endpoints

Part A: Safety and tolerability parameters following single doses of GSK2212836 test formulation including adverse events, clinical laboratory, ECGs and vital signs assessments.
24 hours
Part A: Secondary PK parameters including: tmax, t1/2 and baseline-corrected AUC(0-24h)
24 hours
Part B: Safety and tolerability parameters following repeat doses of GSK2212836 test formulation including adverse events, clinical laboratory, ECGs and vital signs assessments
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part AEXPERIMENTALThree groups of sixteen healthy subjects will be randomized to single doses of 3 different formulations of GSK2212836.
Part BEXPERIMENTALFour cohorts of at least 10 subjects will participate in a 2-week repeat dose period with 4 dose levels (based on data obtained in Part A) of the GSK2212836 test formulations or placebo.

Interventions

NameTypeDescription
GSK2212836DRUGTreatment A - GSK2212836 test formulation 1, Treatment B - GSK2212836 test formulation 2, or Treatment C -GSK2212836 marketed formulation.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including \[me...

Countries:United States
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Frequently asked questions about GSK2212836

What is GSK2212836 used for?

GSK2212836 is an investigational small molecule being developed for cardiovascular disease. It is currently in Phase 1 clinical development and has been studied in a completed clinical trial involving patients with cardiovascular disease.

Who is developing GSK2212836?

GSK2212836 is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for cardiovascular disease.

What phase is GSK2212836 in?

GSK2212836 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial for the drug has been completed.

What clinical trials is GSK2212836 in?

GSK2212836 has been studied in a completed Phase 1 clinical trial with the identifier NCT00996268. The trial was an open-label, single-dose, randomized, parallel group study followed by single-blind repeat dosing, conducted in the United States with 46 participants.

Is GSK2212836 the same as another drug?

GSK2212836 is the primary name for this investigational drug. No alternative names have been reported for this compound in clinical development for cardiovascular disease.