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GSK1349572 formulation AP

Phase 1

Infection, Human Immunodeficiency Virus | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

GSK1349572 formulation AP · 1 trial · 1 indication

Phase 1 1
NCT01098513GSK1349572 Relative Bioavailability StudyInfection, Human Immunodeficiency Virus
COMPLETED24 Analytics
PHASE1COMPLETED
GSK1349572 Relative Bioavailability Study
Infection, Human Immunodeficiency VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma GSK1349572 AUC(0-infinity), AUC(0-t), and Cmax.
48 hours

Secondary Endpoints

Plasma GSK1349572 t½, tlag, tmax, C24, Vdss/F, CL/F, and MRT.
48 hours
Safety and tolerability parameters, including adverse events, concurrent medication, clinical laboratory screens, ECG, and vital signs assessments.
10 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part AEXPERIMENTALSubjects will be randomized in a three-way crossover design to receive a single dose of each of three different tablet formulations of GSK1349572 50 mg (2 tablets). Formulation AP, AW and AX.
Part BEXPERIMENTALA total of 18 subjects who complete Part A will return for Part B. Subjects from Part A will be asked to participate on a first come first served basis until there are 18 subjects, at which time enrolment to Part B will be closed. Part B will be a three way crossover design using either formulation AW or AX depending upon the results from Part A. Subjects will receive a single dose of 50 mg GSK1349572 with either a low fat, moderate fat or high fat meal in each period.

Interventions

NameTypeDescription
GSK1349572 formulation APDRUGGSK1349572 50 mg single dose fasted.
GSK1349572 formulation AWDRUGGSK1349572 formulation AW 50 mg single dose in Part A and 75 to 200 mg fasted or with moderate or high fat meal in Part B.
GSK1349572 formulation AXDRUGGSK1349572 formulation AX 50 mg in Part A and 75-200 mg fasted or with a moderate or high fat meal in Part B
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than or equla to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation in...

Countries:United States
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Frequently asked questions about GSK1349572 formulation AP

What is GSK1349572 formulation AP used for?

GSK1349572 formulation AP is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus (HIV) infection. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes GSK1349572 formulation AP?

GSK1349572 formulation AP is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate this investigational drug for HIV infection.

What phase is GSK1349572 formulation AP in?

GSK1349572 formulation AP is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. The Phase 1 trial has been completed, and the drug remains under evaluation for the treatment of HIV infection.

What clinical trials is GSK1349572 formulation AP in?

GSK1349572 formulation AP has one completed clinical trial, NCT01098513, titled "GSK1349572 Relative Bioavailability Study." This Phase 1 study enrolled 24 participants in the United States, including healthy volunteers, and evaluated the drug's relative bioavailability.

Is GSK1349572 formulation AP the same as dolutegravir?

GSK1349572 formulation AP is an investigational drug being developed by GSK plc for HIV infection. No alternative names have been disclosed for this specific formulation. It is currently in Phase 1 clinical development and has not been approved.