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GSK2190915 milled

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

GSK2190915 milled is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in humans.

Who makes GSK2190915 milled?

GSK2190915 milled is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is GSK2190915 milled in?

GSK2190915 milled is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in early-stage trials to assess its absorption and bioavailability in the body.

What clinical trials is GSK2190915 milled in?

GSK2190915 milled has one completed clinical trial registered under NCT01318980, titled 'A Single Dose Study to Assess the Regional Absorption and Bioavailability of 100mg GSK2190915A.' This Phase 1 study enrolled 14 female participants in the United Kingdom and was a controlled, non-randomized trial.

Is GSK2190915 milled the same as GSK2190915A?

Yes, GSK2190915 milled is the same compound as GSK2190915A. The clinical trial NCT01318980 refers to the drug as GSK2190915A, and the milled formulation is the specific version being studied for its absorption and bioavailability characteristics.