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GSK1605786 ChemoCentryx: formulation A

Phase 1

Crohn's Disease | Small molecule | Gastrointestinal |GSK plc|Last Updated: Jul 18, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

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Clinical trial landscape

GSK1605786 ChemoCentryx: formulation A · 1 trial · 1 indication

Phase 1 1
NCT01114607A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy SubjectsCrohn's Disease
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects
Crohn's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma GSK1605786 parameters: AUC(0-∞), AUC(0-t), Cmax.
2-4 weeks after the last subject last visit

Secondary Endpoints

Plasma GSK1605786 parameters: AUC(0-24), %AUCex, tlag, tmax, t1/2
2-4 weeks after the last subject last visit
Safety and tolerability parameters including vital signs, ECGs, clinical laboratory
Results will be monitered in real time from screening through to the follow-up visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment sequence ABCDEEXPERIMENTALEligible subjects will be randomized in sequence ABCDE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
Treatment sequence ABDECEXPERIMENTALEligible subjects will be randomized in sequence ABDEC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
Treatment sequence ABECDEXPERIMENTALEligible subjects will be randomized in sequence ABECD and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
Treatment sequence ABCEDEXPERIMENTALEligible subjects will be randomized in sequence ABCED and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= a film coated tablet of GSK1605786 GSK formulation 500 mg once daily and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
Treatment sequence ABDCEEXPERIMENTALEligible subjects will be randomized in sequence ABDCE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
Treatment sequence ABEDCEXPERIMENTALEligible subjects will be randomized in sequence ABEDC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
Treatment sequence BACDEEXPERIMENTALEligible subjects will be randomized in sequence BACDE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
Treatment sequence BADECEXPERIMENTALEligible subjects will be randomized in sequence BADEC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
Treatment sequence BAECDEXPERIMENTALEligible subjects will be randomized in sequence BAECD and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
Treatment sequence BACEDEXPERIMENTALEligible subjects will be randomized in sequence BACED and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
Treatment sequence BADCEEXPERIMENTALEligible subjects will be randomized in sequence BADCE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
Treatment sequence BAEDCEXPERIMENTALEligible subjects will be randomized in sequence BAEDC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.

Interventions

NameTypeDescription
GSK1605786 ChemoCentryx: formulation ADRUGChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation BDRUGGSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation CDRUGGSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation DDRUGGSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation EDRUGGSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). 2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical hi...

Countries:United States
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Frequently asked questions about GSK1605786 ChemoCentryx: formulation A

What is GSK1605786 used for?

GSK1605786 is an investigational small molecule being developed for Crohn's Disease. It is currently in Phase 1 clinical development. The drug is being studied to assess the relative bioavailability of four new formulations in healthy subjects, as part of the development process for this gastrointestinal condition.

Who makes GSK1605786?

GSK1605786 is being developed by GSK plc, a global pharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's formulations for potential use in Crohn's Disease.

What phase is GSK1605786 in?

GSK1605786 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a Phase 1 trial to assess the relative bioavailability of four new formulations in healthy subjects.

What clinical trials is GSK1605786 in?

GSK1605786 is being studied in one completed Phase 1 clinical trial, identified as NCT01114607. This trial, titled 'A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects,' enrolled 24 participants in the United States. The study was controlled and randomized.

Is GSK1605786 the same as ChemoCentryx?

GSK1605786 is associated with ChemoCentryx, as indicated in its name 'GSK1605786 ChemoCentryx: formulation A.' However, the drug is being developed by GSK plc. This naming suggests a collaboration or licensing arrangement, but specific details of the relationship are not provided in the available information.