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GSK2190915 Milled

Phase 1

Asthma | Small molecule | Respiratory |GSK plc|Trials Updated: Aug 3, 2017

GSK2190915 Milled target and mechanism

ModalitySmall molecule

Also known as GSK2190915 Milled Tablet

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

GSK2190915 Milled clinical trials

GSK2190915 Milled · 1 trial · 1 indication

Phase 1 1
NCT01318980A Single Dose Study to Assess the Regional Absorption and Bioavailability of 100mg GSK2190915AAsthma
COMPLETED14 Analytics
PHASE1COMPLETED
A Single Dose Study to Assess the Regional Absorption and Bioavailability of 100mg GSK2190915A
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Characterisation of the maximum concentration (Cmax), the time of Cmax (tmax) and Area Under the plasma concentration-time Curve (AUC) for intravenous and oral pharmacokinetics
1 month
Determination of AUC data for all routes of administration to permit calculation of relative and absolute bioavailability where appropriate.
1 month
Assessment of regiospecific bioavailability of GSK2190915A based on tmax, Cmax, and AUC to assist in subsequent oral formulation/delivery options for GSK2190915A
1 month

Secondary Endpoints

To collect further information about the safety and tolerability of GSK2190915A by assessing: physical examination, safety laboratory tests, vital signs, electrocardiogram (ECG), adverse events.
1 month
Quantitative and cumulative recovery of radiocarbon in urine and faeces to permit an assessment of deposition route for intravenous GSK2190915A.
1 month
Collection of bile to allow profiling of metabolites of GSK2190915A.
1 month
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Period 1 Cohort 1 - GSK2190915 100mgEXPERIMENTALPeriod 1 - GSK2190915 100mg tablet.
Period 1 Cohort 2 - GSK2190915 100mg plus microtracerEXPERIMENTALPeriod 1 - GSK2190915 100mg tablet plus \[14C\] radiolabelled GSK2190915 microtracer solution.
Period 2 GSK2190915 100mg to proximal small bowelEXPERIMENTAL100mg of ground half 200mg GSK2190915 tablet administered to the proximal small bowel via Enterion capsule.
Period 3 GSK2190915 100 mg to distal small bowelEXPERIMENTAL100mg of ground half 200mg GSK2190915 tablet administered to the distal small bowel via Enterion capsule.
Period 4 - GSK 100mg enteric-coated tabletEXPERIMENTAL100mg enteric-coated GSK2190915 coated tablet.

Interventions

NameTypeDescription
GSK2190915 100mg milled tabletDRUGTaken orally
[14C] radiolabelled GSK2190915 solutionDRUGMicrotracer solution
GSK2190915 100mg milled tablet administered to the proximal small bowel.DRUGGround half of a 200mg tablet. Administered via Enterion capsule.
GSK2190915 100mg milled tablet administered to the distal small bowel.DRUGGround half of a 200mg tablet. Administered via Enterion capsule.
GSK2190915 100mg enteric-coated tablet.DRUGTaken orally
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy females as determined by an experienced study physician, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and electrocardiogram (ECG). A subject with a clinical abnormality or laboratory parameter...

Countries:United Kingdom
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Frequently asked questions about GSK2190915 Milled

What is GSK2190915 Milled?

GSK2190915 Milled is an investigational small molecule developed by GSK plc for asthma. It is a milled tablet formulation of GSK2190915, specifically a 100mg milled tablet, studied in a Phase 1 clinical trial. The drug has not been approved and remains in clinical development.

What is GSK2190915 Milled used for?

GSK2190915 Milled is being studied for the treatment of asthma. It is an investigational therapy and has not been approved for any indication. The only clinical trial to date enrolled healthy female volunteers to assess the drug's absorption and bioavailability.

Who is developing GSK2190915 Milled?

GSK2190915 Milled is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 trial evaluating this milled tablet formulation for asthma.

What phase is GSK2190915 Milled in?

GSK2190915 Milled is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not received FDA approval.

What clinical trials is GSK2190915 Milled in?

GSK2190915 Milled has been evaluated in one completed Phase 1 trial, NCT01318980, titled "A Single Dose Study to Assess the Regional Absorption and Bioavailability of 100mg GSK2190915A." The trial enrolled 14 healthy female volunteers in the United Kingdom and is now completed.