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GSK2251052

Phase 1

Community-acquired Infection | Small molecule | Infectious Disease |GSK plc|Last Updated: Jul 7, 2017

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

GSK2251052 · 2 trials · 2 indications

Phase 1 2
NCT01267968An Open-label, Randomized, Single Period, Parallel-Cohort Study To Evaluate Serum and Pulmonary Pharmacokinetics Following Single and Multiple Dose Administration of Intravenous GSK2251052 in Healthy Adult SubjectsCommunity-acquired Infection
COMPLETED25 Analytics
NCT01262885A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult SubjectsInfections, Bacterial
COMPLETED84 Analytics
PHASE1COMPLETED
An Open-label, Randomized, Single Period, Parallel-Cohort Study To Evaluate Serum and Pulmonary Pharmacokinetics Following Single and Multiple Dose Administration of Intravenous GSK2251052 in Healthy Adult Subjects
Community-acquired Infection
NCT0126796825
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PHASE1COMPLETED
A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects
Infections, Bacterial
NCT0126288584
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Study Endpoints

Primary Endpoints

Epithelial lining fluid (ELF)/ plasma ratios for GSK2251052 at early, mid, and late dosing interval timepoints following intravenous administration of 1500 mg q12h.
up to 3 days
Alveolar macrophage (AM)/ plasma ratios for GSK2251052 at early, mid, and late dosing interval timepoints following intravenous administration of 1500 mg q12h.
up to 3 days
Adverse event reporting, clinical laboratory tests, vital signs, cardiac monitoring, urinalysis, and clinical monitoring/observation.
within 35 days of first dose
Plasma AUC(0-t), AUC(0-inf), Cmax, tmax, t1/2, Ae, fe, and CLr of GSK2251052 as data permit.
within 14 days of first dose

Secondary Endpoints

Plasma AUC (0-t), Cmax, CL, Vss, and t½, following intravenous administration of GSK2251052, as permitted by the data.
up to 3 days
GSK2251052 concentrations in urine following single and repeat dose administration
up to 3 days
Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, cardiac monitoring, and vital signs assessments.
up to 14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALGSK2251052 1500 mg Single dose (i.v., 60 min)
Cohort 2EXPERIMENTALGSK2251052 1500 mg IV q12h x 5 doses infused over 60 minutes
Part A Cohort 1EXPERIMENTALGSK2251052 500 mg (6 subjects), Placebo (1 subject)
Part A Cohort 2EXPERIMENTALGSK2251052 1000 mg (6 subjects), Placebo (1 subject)
Part A Cohort 3EXPERIMENTALGSK2251052 2000 mg (6 subjects), Placebo (1 subject)
Part A Cohort 2 - fedEXPERIMENTALGSK2251052 1000 mg (6 subjects), Placebo (1 subject)
Part B Cohort 1EXPERIMENTALPlacebo (3 subjects), GSK2251052 (9 subjects) dose to be determined
Part B Cohort 2EXPERIMENTALPlacebo (3 subjects), GSK2251052 (9 subjects) dose to be determined
Part B Cohort 3EXPERIMENTALPlacebo (3 subjects), GSK2251052 (9 subjects) dose to be determined
Part A Cohort 4EXPERIMENTALPlacebo (1 subject), GSK2251052 (6 subjects) dose to be determined

Interventions

NameTypeDescription
GSK2251052DRUG1500 mg (dosing detailed in Arm description)
PlaceboDRUGmatching placebo tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin \< or = 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). Abnormal LFT tests may be repeated once at the discretion of the Investigator. If an abnormality is repeated, the ...

Countries:United StatesAustralia
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Frequently asked questions about GSK2251052

What is GSK2251052 used for?

GSK2251052 is an investigational small molecule being developed for bacterial infections, including community-acquired infections. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy subjects.

What does GSK2251052 target?

GSK2251052 is a small molecule antibacterial agent. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for the treatment of bacterial infections, including community-acquired infections.

Who makes GSK2251052?

GSK2251052 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is GSK2251052 in?

GSK2251052 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total of 109 participants enrolled across studies in Australia and the United States.

What clinical trials is GSK2251052 in?

GSK2251052 has been studied in two completed Phase 1 clinical trials. NCT01262885 evaluated single and repeat oral doses in healthy adults in Australia, while NCT01267968 assessed intravenous administration in healthy male subjects in the United States. Both trials focused on safety, tolerability, and pharmacokinetics.

Is GSK2251052 the same as other drugs?

GSK2251052 is the primary name for this investigational drug. No alternative names have been identified in the available information. It is a unique small molecule being developed by GSK plc for bacterial infections.