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GSK2110183 Gelatin

Phase 1

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Nov 13, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02040480Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of AfuresertibPHASE1 COMPLETED 18 — — Feb 5, 2014Apr 4, 2014Nov 13, 20171 Australia
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Study Endpoints
Primary Endpoints
Composite of pharmacokinetic (PK) parameters to determine relative bioavailability of afuresertib after administering it as a single dose in an original gelatin capsule in the fasted state and in a newly formulated IR tablet in the fed and fasted state.
PK Samples will be collected Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 120, and 168 hours post-dose

PK parameters include: area under the plasma concentration-time curve from time zero to infinity (AUC \[0-infinity\]), area under the plasma concentration time curve from time zero to last time of quantifiable concentration (AUC \[0-t\]), maximum observed plasma concentration (Cmax), and time to Cmax (tmax).

Secondary Endpoints
Number of subjects with adverse events (AEs).
Up to 9 weeks
Clinical laboratory parameter assessment as a measure of safety and tolerability
Up to 9 weeks
Concomitant medications review as a measure of safety and tolerability
Up to 9 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): ABC
Sequence 2EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): ACB
Sequence 3EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): BAC
Sequence 4EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): BCA
Sequence 5EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): CAB
Sequence 6EXPERIMENTALParticipants will receive treatment in following sequence in each of the three study periods (one treatment per period): CBA
Interventions
NameTypeDescription
GSK2110183 Gelatin CapsuleDRUGWhite opaque hard gelatin capsule with a unit dose strength of 25 milligrams (mg) for oral administration
GSK2110183 IR TabletDRUGWhite round biconvex film coated IR tablet with a unit dose strength of 25 mg for oral administration
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provided signed written informed consent * Healthy Male or female between 18 and 40 years of age inclusive, at the time the informed consent is obtained. * Body weight \>=50 kilograms (kg) and body mass index (BMI) of \>=18 and \<= 32 kg/meter square (m\^2). * A female subject...

Countries:Australia
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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