Recent Updates
Recently added Catalysts

GSK2248761 WBM

Phase 1

Infections, Human Immunodeficiency Virus and Herpesviridae | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 8, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

GSK2248761 WBM · 1 trial · 2 indications

Phase 1 1
NCT01209117A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435Infections, Human Immunodeficiency Virus and Herpesviridae
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435
Infections, Human Immunodeficiency Virus and HerpesviridaeUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma GSK2248761 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity))
5 weeks
Plasma GSK2248761 Area under the concentration-time curve over the dosing interval (AUC (0 - t))
5 weeks
Plasma GSK2248761 observed concentration 24 hours after dose (C24)
5 weeks
Plasma GSK2248761 Maximum observed concentration (Cmax)
5 weeks

Secondary Endpoints

Safety and tolerability parameters, including adverse events
5 weeks
concurrent medication
5 weeks
Clinical laboratory screens
5 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Periods 1 - 4EXPERIMENTALSubjects will be randomized in a cross over fashion to receive the GSK2248761 WBM capsule formulation or one of three WBM tablet formulations in one of four sequences.
Period 5EXPERIMENTALSubjects in Part B will receive a formulation of GSK2248761 200mg WBM Tablet chosen from Periods 1 - 4 in part A in the fed state (moderate fat meal).

Interventions

NameTypeDescription
GSK2248761 WBM CapsuleDRUG200 mg GSK2248761 WBM capsule (reference) 2 X100mg
GSK2248761 WBM Tablet Formulation 1DRUGGSK2248761 WBM Tablet 200mg manufacturing process 1
GSK2248761 WBM Tablet Formulation 2DRUGGSK2248761 WBM Tablet 200mg manufacturing process 2
GSK2248761 WBM Tablet Formulation 3DRUGGSK2248761 WBM Tablet 200mg manufacturing process 3
GSK2248761 WBM TabletDRUGGSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about GSK2248761 WBM

What is GSK2248761 WBM used for?

GSK2248761 WBM is an investigational small molecule being developed for infections, including Human Immunodeficiency Virus (HIV) and Herpesviridae infections. It is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes GSK2248761 WBM?

GSK2248761 WBM is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for infectious disease indications.

What phase is GSK2248761 WBM in?

GSK2248761 WBM is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is GSK2248761 WBM in?

GSK2248761 WBM has one completed clinical trial, NCT01209117, titled "A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435." This Phase 1 study enrolled 24 healthy adult subjects in the United States.

Is GSK2248761 WBM the same as GSK2248761?

GSK2248761 WBM is a formulation of the drug GSK2248761. The trial NCT01209117 specifically assessed the relative bioavailability of tablet formulations of GSK2248761, indicating that WBM refers to a particular tablet formulation of the same active compound.