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GSK256073A

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00608699A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy VolunteersPHASE1 COMPLETED 24 — — Dec 1, 2007Apr 1, 2008Apr 30, 20121 United States
NCT00551694A Second Study to Determine the Effect of GSK256073A on HVTsPHASE1 COMPLETED 4 — — Oct 1, 2007Dec 1, 2007Jun 4, 20121 United States
NCT00488449Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy VolunteersPHASE1 COMPLETED 56 — — Jun 1, 2007Nov 1, 2007Jun 4, 20121 United States
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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 — 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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