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1278863

Phase 1

Kidney Disease | Small molecule | Nephrology |GSK plc|Last Updated: Jun 22, 2017

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00840320Repeat Dose Safety Study for Compound to Treat AnemiaPHASE1 COMPLETED 24Mar 13, 2009Sep 2, 2009Jun 22, 20171 Australia
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Study Endpoints
Primary Endpoints
adverse events reporting
throughout study
Safety Labs (hematology)
Screening, Days -1, 1-3, 5, 7, 9, 11, 14-18, 21, 25, 28
vital signs (blood pressure and heart rate)
Days 1-15, 28
12-lead ECG
Screening, Days 1-2, 4, 6, 8, 10, 12, 14, 28
dual-lead cardiac monitoring (telemetry monitoring)
Days -1 to 3, 14
clinical monitoring/observation
throughout
Safety Labs (Chemistry)
Screening, Days -1, 1-3, 7, 10, 14-15, 17, 21, 28
Safety Labs (Urinalysis)
Screening, Days -1, 1-3, 7, 10, 14-15, 17, 21, 28
Secondary Endpoints
AUC(0-∞) on Day 1, AUC(0-τ), Cmax, tmax and t1/2, on Days 1 and 14
Days 1-2, 4, 6, 8, 10, 12, 14-18
Trough plasma concentrations at the end of the dosing interval
Days 2, 4, 6, 8, 10 and 12
Hemoglobin actual values, rate of rise, maximum change from baseline, and rate of decline following stopping of dosing
Days 1, 7, 14, 21, 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALRepeat doses of active at escalating doses
2PLACEBO_COMPARATORRepeat doses of placebo
Interventions
NameTypeDescription
1278863DRUG15mg, 25mg, 50mg, 150mg
PlaceboDRUGmatching placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. 2. Male or female between 18 and 55 years of age, inclusive. 3. A female subject must be of non-childbeari...

Countries:Australia
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