Recently added Catalysts

GSK2140944 Drug single dose of, and dose to be determined

Phase 1

Infections, Respiratory Tract | Small molecule | Infectious Disease |GSK plc|Last Updated: May 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED

Total Trials1

Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

GSK2140944 Drug single dose of, and dose to be determined · 1 trial · 1 indication

Phase 1 1

NCT01615796Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV DosesInfections, Respiratory Tract

COMPLETED86 Analytics

PHASE1COMPLETED

Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV Doses

Infections, Respiratory Tract

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Study Endpoints

Primary Endpoints

Composite of pharmacokinetic (PK) parameters of GSK2140944 including area under the curve following single dose administration.

Part A up to 4 days

Measurements include area under the plasma concentration curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity), AUC over the dosing interval AUC(0-tau). AUC (0-12) and AUC(0-24).

Composite of PK parameters for GSK2140944 following single dose administration

Part A up to 4 Days

Measurements include maximum observed concentration (Cmax), systemic clearance of parent drug (CL). volume of distribution at steady state of parent drug after intravascular administration (Vdss), Mean residence time (MRT) and terminal phase half-life (t1/2)

Composite of PK parameters for GSK2140944 including area under the curve following repeat dose administration.

Part B Days 4, 7, 10 and 14

Measurements include AUC from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity), AUC over the dosing interval AUC(0-tau). AUC (0-8), AUC (0-12) and AUC(0-24).

Composite of PK parameters for GSK2140944 following repeat dose administration.

Part B Days 4, 7, 10 and 14

Measurements include Cmax, CL. Vdss, MRT and t1/2.

Composite of PK parameters for GSK2140944 following repeat dose administration including maximum concentration, area under the curve, accumulation ratio and clearance of parent drub.

Part B Days 4, 7, 10 and 14

Measurements include AUC(0-tau). Cmax, pre-dose (trough) concentration at the end of the dosing interval (Cτ), accumulation ratio (Ro) and CL

GSK2140944 safety parameters - adverse events

Part A change from baseline for 15 Days. Part B change from baseline for up to 28 Days

GSK2140944 safety parameters - telemetry

Part A change from baseline for 15 Days. Part B change from baseline for up to 28 Days

GSK2140944 safety parameters - absolute values and changes over time of hematology, clinical chemistry and urinalysis

Part A change from baseline for 15 Days. Part B change from baseline for up to 28 Days

GSK2140944 safety parameters - vital signs (blood pressure, heart rate, temperature)

Part A change from baseline for 15 Days. Part B change from baseline for up to 28 Days

GSK2140944 safety parameters - Electrocardiogram (ECG) measurements

Part A change from baseline for 15 Days. Part B change from baseline for up to 28 Days

Secondary Endpoints

A composite of pharmacokinetic parameters including dose proportionality following single and repeat doses of GSK2140944.

44 Days in Part A, 7, 10 and 14 Days in Part B

A composite of pharmacokinetic urinary parameters to estimate the urinary excretion of unchanged GSK2140944 following a therapeutically relevant dose and higher single dose in healthy volunteers.

4 Days in Part A

A composite of pharmacokinetic parameters to estimate the absolute bioavailability of the oral capsule formulation of GSK2140944 as compared to the IV formulation following single equivalent doses in healthy volunteers.

4 Days in Part A

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Study Design & Arms

AllocationRANDOMIZED

MaskingSINGLE

ModelSINGLE_GROUP

PurposeOTHER

Treatment Arms

Arm	Type	Description
Cohort A1	EXPERIMENTAL	GSK2140944 200mg single dose
Cohort A2	EXPERIMENTAL	GSK2140944 600mg single dose
Cohort A3	EXPERIMENTAL	GSK2140944 1200mg single dose
Cohort A4	EXPERIMENTAL	GSK2140944 1800mg single dose
Cohort A5	EXPERIMENTAL	GSK2140944 1800mg single dose
Cohort A6	EXPERIMENTAL	GSK2140944 dose to be determined, single dose
Cohort B1	EXPERIMENTAL	GSK2140944 400 mg repeat dose BID up to 7 days
Cohort B2	EXPERIMENTAL	GSK2140944 750 mg repeat dose BID up to 7 days
Cohort B3	EXPERIMENTAL	GSK2140944 1000 mg repeat dose BID up to 7 days
Cohort B4	EXPERIMENTAL	GSK2140944 to be determined repeat dose BID up to 7 days
Cohort B5	EXPERIMENTAL	GSK2140944 to be determined repeat dose TID up to 14 days
Cohort B6	EXPERIMENTAL	GSK2140944 to be determined repeat dose TID up to 14 days

Interventions

Name	Type	Description
Part A: GSK2140944 Drug single dose of 200mg, 600mg, 1200mg, 1800 mg, and dose to be determined	DRUG	Subjects receive a single dose of GSK2140944
Part B: GSK2140944 Repeat Drug dose of 400mg, 750mg, 1000 mg, and dose to be determined	DRUG	Subjects will receive repeat doses of GSK2140944 BID/TID for up to 14 Days

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Eligibility Criteria

Age Range18 Years to 60 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than and equal to 1.5xULN (isolated bilirubin less than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%). * Healthy as determined by a responsible and experienced physician, based on a medi...

Countries:Australia

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