Endotoxin Challenge Study For Healthy Men and Women

NCT00515268 | Completed Phase 1

• 1 other identifier: IPC103711
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

LPS challenge,; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure

  24 hours

Secondary Outcomes (1)

• Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8

  Day 1,Day 7&DAY 8

Study Arms (2)

Subjects receiving GSK256066

EXPERIMENTAL

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.

Drug: GSK256066

Subjects receiving placebo

PLACEBO COMPARATOR

Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER.

Drug: Placebo

Interventions

GSK256066 DRUG

GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.

Subjects receiving GSK256066

Placebo DRUG

Subjects will receive placebo inhaler.

Subjects receiving placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

Related Links

• Results for study IPC103711 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: September 27, 2007
• Primary Completion: April 23, 2008
• Study Completion: April 23, 2008
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

DE (1)