Recent Updates
Recently added Catalysts

an undetermined dose of GSK1292263

Phase 1

Dyslipidaemias | Small molecule | Metabolic |GSK plc|Last Updated: Jul 7, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00783549A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.PHASE1 COMPLETED 76 — — Sep 4, 2008Mar 31, 2009Jul 7, 20171 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety and tolerability parameters including adverse events, clinical laboratory, electrocardiogram, and vital signs assessments.
Up to 4 days
Pharmacokinetic parameters, maximum observed plasma drug concentration, time to maximum observe.
Up to 4 days
Secondary Endpoints
Pharmacodynamic endpoints
Up to four days.
• Pharmacokinetic parameters following a dose, with and without food, and bioavailability
Up to four days.
Relationships betwen drug exposures and pharmacodynamic parameters, safety, and tolerability, as appropriate.
Up to four days.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL6 active 2 placebo
Cohort 2EXPERIMENTAL9 active 3 placebo
Cohort 3EXPERIMENTALOptional cohort
Cohort 4EXPERIMENTAL12 active
Cohort 5EXPERIMENTAL12 active
Interventions
NameTypeDescription
an undetermined dose of GSK1292263DRUGGSK investigational product or placebo
ascending dose of GSK1292263DRUGAscending dose based on target exposures or placebo
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Male or female between 18 and 55 years of age * A female subject is eligible to participate if she is of non-childbearing potential * Male subjects must agree to use one of the contraception methods listed in the protocol * BMI within the range 20 - 29.9 kg/m2 * Capabl...

Countries:United States
Unlock Eligibility Criteria