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-GSK3191607

Phase 1

Malaria, Falciparum | Small molecule | Infectious Disease |GSK plc|Last Updated: Sep 13, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02737007A Microdose Study in Healthy Subjects to Describe Intravenous Pharmacokinetics of GSK3191607PHASE1 COMPLETED 6 — — Apr 18, 2016May 12, 2016Sep 13, 20181 United Kingdom
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Study Endpoints
Primary Endpoints
Maximum observed concentration (Cmax) of GSK3191607 in plasma following a single intravenous (IV) microdose
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Terminal phase half life (t1/2) of GSK3191607 following a single IV microdose
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Time of occurrence of Cmax (tmax) of GSK3191607 following a single IV microdose
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
AUC(0-t) of GSK3191607 following a single IV microdose
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion

AUC(0-t) is the area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration.

AUC(0-infinity) of GSK3191607 following a single IV microdose
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion

AUC(0-infinity) is the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.

Systemic clearance (CL) of GSK3191607 following a single IV microdose
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
GSK3191607 volume of distribution at steady state (Vss)
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Cmax of radioactive drug-related material (RDM) in plasma following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion

RDM is a measure of total radioactivity. Cmax of RDM will be compared with that of the parent drug (GSK3191607).

T1/2 of RDM following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion

T1/2 of RDM will be compared with that of the parent drug.

Tmax of RDM following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion

Tmax of RDM will be compared with that of the parent drug.

AUC(0-t) of RDM following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion

AUC(0-t) of RDM will be compared with that of the parent drug.

AUC(0-infinity) of RDM following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion

AUC(0-infinity) of RDM will be compared with that of the parent drug.

Amount of RDM excreted in urine (Ae) following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0-24 hours and 24-48 hours after the start of infusion

Subjects will be asked to void their bladders before study treatment administration. A blank urine sample will be collected pre-dose.

Secondary Endpoints
Whole-Blood:Plasma ratio of Cmax of RDM following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of tmax of RDM following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
Whole-Blood:Plasma ratio of t1/2 of RDM following a single IV microdose of [14C]-GSK3191607
Pre-dose; and 0.25, 0.75, 1.5, 3, 6, 8, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, and 336 hours following start of infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[14C]-GSK3191607 IV MicrodoseEXPERIMENTALSubjects will receive a single microdose of 100 micrograms (mcg) of \[14C\]-GSK3191607 by intravenous infusion over 15 minutes on Day 1 of the study.
Interventions
NameTypeDescription
[14C]-GSK3191607DRUG\[14C\]-GSK3191607 is a solution to be administered intravenously as a single dose infusion over 15 minutes. It is a radio-labeled product; 100 mcg of \[14C\]-GSK3191607 contains approximately 7.4 kilobecquerel (kBq) of \[14C\] radioactivity.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ...

Countries:United Kingdom
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