Endotoxin Challenge Study For Healthy Men and Women

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 1

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: GSK256066
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00515268
IPC103711

Details and patient eligibility

About

The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.

Enrollment

37 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy males and females (contraception restrictions),
  • 18-50yrs,
  • BMI 19-31kg/m2,
  • Non-smokers,
  • FEV1 >/= 80% predicted

Exclusion criteria

  • Abnormal troponin and/or CK MB,
  • Participated in any GSK study involving the administration of COA for >/= 21 days.

Trial design

37 participants in 2 patient groups, including a placebo group

Subjects receiving GSK256066
Experimental group
Description:
Eligible subjects will be randomized to receive GSK256066 with inhaled doses of 25 micrograms or 87.5 micrograms once daily for 7 days, administered via an ACCUHALER.
Treatment:
Drug: GSK256066
Subjects receiving placebo
Placebo Comparator group
Description:
Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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