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GSK1265744 injectable

Phase 1

Infections, Human Immunodeficiency Virus and Herpesviridae | Small molecule | Infectious Disease |GSK plc|Last Updated: May 20, 2013

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 Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01756131A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy SubjectsPHASE1 COMPLETED 72 — — Sep 1, 2010Dec 1, 2012May 20, 2013 - —
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Study Endpoints
Primary Endpoints
GSK1265744 safety and tolerability parameters including: the collection of adverse events
12 weeks
Change from baseline values in clinical laboratory assessments
12 weeks
Change from baseline for Electrocardiogram (ECG) assessments
12 weeks
Change from baseline valuse in vital sign assessments (systolic and diastolic blood pressure and pulse rate)
12 weeks
Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
12 weeks

GSK1265744 pharmacokinetic parameters: area under the plasma concentration time curve from time zero to the last quantifiable time points (AUC(0-tau)), area under the plasma concentration time curve from time zero to infinity (AUC(0-infinity)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), apparent terminal phase half-life for LAP administration (t½), lambda z as a measure of absorption rate constant

GSK1265744 concentration at 1 month post-dose (C720 hours)
4 weeks
Secondary Endpoints
Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks.
12 weeks
Composite of pharmacokinetic parameters for dose proportionality: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
12 weeks
GSK1265744 C720 hours following single dose administration at different doses for the assessment of dose proportionality
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL100 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 2EXPERIMENTAL200 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 3EXPERIMENTAL400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 4EXPERIMENTAL800 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 5EXPERIMENTAL100 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing
Cohort 6EXPERIMENTAL200 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing
Cohort 7EXPERIMENTAL400 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing
Cohort 8EXPERIMENTAL400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 9EXPERIMENTAL400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Interventions
NameTypeDescription
GSK1265744 injectable suspensionDRUG200 milligram per milliliter sterile solution for injection
Placebo to match injectable suspensionOTHERplacebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range ...

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