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GSK256073A

Phase 1

Healthy Subjects | Small molecule | Cardiovascular |GSK plc|Last Updated: Jun 4, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

GSK256073A · 3 trials · 2 indications

Phase 1 3
NCT00608699A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy VolunteersHealthy Subjects
COMPLETED24 Analytics
NCT00551694A Second Study to Determine the Effect of GSK256073A on HVTsHealthy Subjects
COMPLETED4 Analytics
NCT00488449Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy VolunteersHealthy Subjects
COMPLETED56 Analytics
PHASE1COMPLETED
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Healthy SubjectsUnlock trial analytics
PHASE1COMPLETED
A Second Study to Determine the Effect of GSK256073A on HVTs
Healthy SubjectsUnlock trial analytics
PHASE1COMPLETED
Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
up to 8 hours post dose
Safety and tolerability of GSK256073A and immediate release niacin
up to 36 hours post dose
AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing throughout the study.
throughout the study.
AUC and Cmax
throughout the study
Measures of accumulation ratios throughout the study (Ro, Rp, and Rs)[Period 2]
throughout the study
AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing
throughout the study (Parts A &B)
Measures of accumulation ratios
throughout the study (Ro, Rp, and Rs)[Part B]

Secondary Endpoints

Standard and Secondary pharmacokinetic endpoints of interest
up to 36 hours post dose
Pharmacodynamic response
up to 36 hours post dose
Tmax, t½, Ae, and CLr , Cmax, ss, Ct, t½, Ae, CLr, and accumulation ratios throughout the study
throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Interventions

NameTypeDescription
GSK256073A tablets + IR niacin tabletsDRUGsingle dosing for 4 to 5 sessions
GSK256073A tabletsDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adult males between 18 and 55 years of age, inclusive. * Healthy subjects * Body weight \> 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where: * Subjects with QTc \< 450 msec at screening Exclusion Criteria: * History of significant cardiac arrhythmias * Ac...

Countries:United States
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Frequently asked questions about GSK256073A

What is GSK256073A used for?

GSK256073A is an investigational small molecule being studied in healthy subjects with dyslipidaemias, a condition involving abnormal lipid levels. It is in Phase 1 clinical development for cardiovascular therapeutic use. The drug is not approved and remains in early-stage clinical testing.

Who makes GSK256073A?

GSK256073A is being developed by GSK plc, a pharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics and pharmacodynamics in healthy volunteers.

What phase is GSK256073A in?

GSK256073A is in Phase 1 clinical development. Three Phase 1 trials have been completed, with a total enrollment of 84 participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is GSK256073A in?

GSK256073A has been studied in three completed Phase 1 trials: NCT00488449, which examined pharmacokinetics and pharmacodynamics in 56 healthy volunteers; NCT00551694, a second study in 4 healthy volunteers; and NCT00608699, which assessed the drug's ability to block niacin-induced flushing in 24 male healthy volunteers.

Is GSK256073A the same as niacin?

GSK256073A is not niacin, but it is being studied for its potential to block niacin-induced flushing. In clinical trial NCT00608699, researchers evaluated whether GSK256073A could prevent the flushing side effect commonly associated with niacin treatment in healthy volunteers.