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GSK256073A

Phase 1

Dyslipidaemias | Small molecule | Cardiovascular |GSK plc|Trials Updated: Jun 4, 2012

GSK256073A target and mechanism

ModalitySmall molecule

Also known as GSK256073A tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment84

FDA Designations

No designations recorded

GSK256073A clinical trials

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?

GSK256073A is an investigational small molecule developed by GSK plc for dyslipidaemias, a group of lipid disorders. It has been studied in Phase 1 clinical trials, including research into whether it can block niacin-induced flushing in healthy volunteers. It is not an approved medicine.

What is GSK256073A used for in dyslipidaemias?

GSK256073A is being investigated for dyslipidaemias, conditions marked by abnormal lipid levels in the blood. Its Phase 1 program also evaluated whether the compound could block niacin-induced flushing in healthy volunteers. It remains an investigational agent and is not approved for any use.

Who makes GSK256073A?

GSK256073A is developed by GSK plc, which trades under the ticker GSK. The company sponsored all three Phase 1 trials of the compound, which were conducted in the United States in healthy volunteers.

What phase is GSK256073A in?

GSK256073A is in Phase 1 development. All three of its clinical trials are Phase 1 studies and all three are completed, with no active trials ongoing. The compound is investigational and has not been approved for marketing.

What clinical trials is GSK256073A in?

GSK256073A has been studied in three completed Phase 1 trials: NCT00608699, which tested whether it blocks niacin-induced flushing in 24 healthy male volunteers; NCT00551694, a second study in healthy volunteers with 4 participants; and NCT00488449, a pharmacokinetics and pharmacodynamics study with 56 participants. All were conducted in the United States.