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GSK1265744 Na Salt

Phase 1

Infections, Human Immunodeficiency Virus and Hepatitis | Small molecule | Infectious Disease |GSK plc|Trials Updated: Aug 12, 2016

GSK1265744 Na Salt target and mechanism

ModalitySmall molecule

Also known as GSK1265744 Na Salt Tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

GSK1265744 Na Salt clinical trials

GSK1265744 Na Salt · 1 trial · 1 indication

Phase 1 1
NCT01648257Relative Bioavailability Study of GSK1265744 FormulationsInfections, Human Immunodeficiency Virus and Hepatitis
COMPLETED18 Analytics
PHASE1COMPLETED
Relative Bioavailability Study of GSK1265744 Formulations
Infections, Human Immunodeficiency Virus and HepatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Composite of PK parameters following single oral dose administration of GSK1265744
For 168 hours post dose (36 days)

Plasma GSK1265744 PK parameters: area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time AUC(0-infinity); AUC from time zero to time t, AUC(0-t), and maximum observed concentration, Cmax.

Secondary Endpoints

Composite of PK parameters following single oral dose administration of GSK1265744
For 168 hours post each dose of GSK1265744 (36 days)
Safety and tolerability as assessed by the collection of adverse events
50 days
Safety and tolerability as assessed by change from baseline in clinical laboratory tests
50 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GSK1265744 Na Salt TabletsEXPERIMENTALSubjects will receive single dose of GSK1265744 sodium salt (30 mg) tablet on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 milliliter (mL) of water.
GSK1265744 Free Acid Nanomilled CapsulesEXPERIMENTALSubjects will receive single dose of GSK1265744 free acid nanomilled (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water.
GSK1265744 Free Acid Micronized CapsulesEXPERIMENTALSubjects will receive single dose of GSK1265744 free acid micronized (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water.

Interventions

NameTypeDescription
GSK1265744 Na Salt TabletsDRUGEach tablet contains 30 mg of GSK1265744 sodium salt and excipients.
GSK1265744 Free Acid Nanomilled CapsulesDRUGEach capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients.
GSK1265744 Free Acid Micronized CapsulesDRUGEach capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin =\< 1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, bas...

Countries:United States
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Frequently asked questions about GSK1265744 Na Salt

What is GSK1265744 Na Salt?

GSK1265744 Na Salt is an investigational small molecule developed by GSK plc for infections, human immunodeficiency virus (HIV) and hepatitis. It is in Phase 1 clinical development and has been studied in a relative bioavailability trial of its tablet formulations. It is also known as GSK1265744 Na Salt Tablets.

What is GSK1265744 Na Salt used for?

GSK1265744 Na Salt is being developed for infections, human immunodeficiency virus (HIV) and hepatitis. Its only recorded clinical study enrolled healthy adult volunteers rather than patients, and it was designed to compare the relative bioavailability of different formulations of the drug.

Who makes GSK1265744 Na Salt?

GSK1265744 Na Salt is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 relative bioavailability study of the drug's formulations, which was conducted in the United States.

What phase is GSK1265744 Na Salt in?

GSK1265744 Na Salt is in Phase 1 clinical development. It is investigational and has not been approved for any indication. One Phase 1 trial has been completed, and no active trials are currently recorded for this asset.

What clinical trials is GSK1265744 Na Salt in?

GSK1265744 Na Salt has been studied in one completed Phase 1 trial, NCT01648257, titled Relative Bioavailability Study of GSK1265744 Formulations. The trial enrolled 18 healthy adult volunteers of all sexes in the United States and used a controlled, randomized design without double blinding.

Is GSK1265744 Na Salt the same as GSK1265744 Na Salt Tablets?

Yes, GSK1265744 Na Salt Tablets is another name for GSK1265744 Na Salt. The tablet form was the formulation evaluated in the completed Phase 1 relative bioavailability study NCT01648257, which compared formulations of the drug in 18 healthy volunteers.