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GSK189075A

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Apr 5, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01571661A First-time-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GSK189075A in Healthy Subjects and in Subjects With Type 2 Diabetes MellitusPHASE1 COMPLETED 16 — — Sep 1, 2004Jan 1, 2005Apr 5, 2012 - —
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Study Endpoints
Primary Endpoints
Safety and tolerability change from baseline in laboratory assessments
Part A: Approximately 58 days and Part B: Approximately 38 days.

Hematology, Clinical Chemistry, Urinalysis

Safety and tolerability change from baseline in electrocardiaogram (ECG) reading
Part A: Approximately 58 days and Part B: Approximately 38 days.

12-lead ECG and continuous ECG monitoring.

Safety and tolerability change from baseline in fluid intake
FPart A: Approximately 58 days and Part B: Approximately 38 days.

urine output, and the number of micturations will be recorded.

Safety and tolerability change from baseline in electrolytes
Part A: Approximately 58 days and Part B: Approximately 38 days.

Blood electrolyte concentrations (Na, K, Cl, Ca, Mg and bicarbonate)

Safety and Tolerability change from baseline in creatinine clearance
Part A: Approximately 58 days and Part B: Approximately 38 days.

creatinine clearance (24-hours \[h\])

Composite of pharmacokinetic parameters of GSK189075A, GSK189074A, and GSK279782A
Part A: up to 24 hours post dose for five periods. Part B: For 24 hours post dose for 3 periods. Collected at the following: pre-dose, and 10 min, 20 min, 30 min, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, , 8, 12, 16 and 24h post-dose.

Area under the plasma concentration-time curve \[AUC(0 last)\], Area under the plasma concentration-time curve \[AUC(0-infinity)\], Maximum observed plasma concentration (Cmax), Time to maximum observed plasma concentration (tmax), Plasma elimination half-life (t1/2), Area under the plasma concentration-time curve for the metabolite \[AUCm(0-last)\]/ Area under the plasma concentration-time curve for the parent \[AUCp(0-last)\], and AUCm(0-infinity)/AUCp(0-infinity) ratios.

Parts A and B: plasma glucose concentrations in healthy subjects
Part A: up to 24 hours post dose for five periods. Part B: For 24 hours post dose for 3 periods.
Parts A and B: Urine chemistry lab measurements
measurements will be obtained pre-dose, and over the following intervals: 0-2, 2-4, 4-6, 6-8, 8-12, and 12-24h during the dosing period.

Urine samples for creatinine, glucose, and electrolytes (Na, K, Cl) measurements will be obtained.

Part B: Plasma glucose and insulin concentrations concentrations in subjects with type 2 diabetes mellitus following a 50g oral glucose challenge.
On day -2 predose and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 10, 12 and 24h.
Safety and Tolerability as assessed by numbers of adverse events
Part A: Approximately 58 days and Part B: Approximately 38 days.

number of adverse events collected during study

Safety and Tolerability as assessed by change from baseline in vital sign measurements
Part A: Approximately 58 days and Part B: Approximately 38 days.

Blood pressure and heart rate.

urine glucose concentrations in subjects with type 2 diabetes mellitus following a 50g oral glucose challenge.
On day -2 predose and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 10, 12 and 24h.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A Treatment 1EXPERIMENTALGSK189075A 20mg
Part A Treatment 2EXPERIMENTALGSK189075A 50mg
Part A Treatment 3EXPERIMENTALGSK189075A 150mg
Part A Treatment 4EXPERIMENTALGSK189075A 500mg
Part A Treatment 5EXPERIMENTALGSK189075A 1000mg
PlaceboPLACEBO_COMPARATORPlacebo
Part B Low doseEXPERIMENTALlow dose chosen from Part A
Part B High DoseEXPERIMENTALhigh dose chosen from Part A
Interventions
NameTypeDescription
GSK189075ADRUG20mg, 50mg, 150mg, 500mg, 1000mg or Placebo
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Women must be of non-childbearing potential. Non-childbearing potential is defined as: Post-menopausal females defined as being amenorrhoeic for greater than one year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However, if indica...

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