Protocol Summary for 115360
| Protocol Id: | 115360 |
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| Title: | A Single and Repeat Dose pharmacokinetics/ pharmacodynamics (PK/PD) Study to Characterise theBiomarker Response in Healthy Subjects Treated with the AntiinflammatoryMacrolide Azithromycin |
| Phase: | phase 1 |
| Acronym: | |
| FDA Regulated Intervention?: | No |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Observational |
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| Brief Summary: | This is a two part protocol (Parts A and B) in healthy volunteers evaluating the pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of various biomarkers (e.g., Interleukin-10 (IL-10), Granulocyte macrophage colony-stimulating factor (GM-CSF), mature dendritic cell (MDC), with and without ex vivo lipopolysaccharide (LPS) stimulation) as markers of macrolide anti-inflammatory activity. Part A is a randomized, open-label parallel group study evaluating PK/PD of a single azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory conditions). This information will guide the range of doses to be studied in a first time in humans (FTIH) study of a new chemical entity. Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day for 3 weeks), the dose approximates that used in the treatment of chronic neutrophil related inflammatory conditions. This information will provide insight into whether the biomarker effects change over time on repeat dosing and any potential differences observed between single and repeat doses. |
| Detailed Description: | This is a two part protocol (Parts A and B) in healthy volunteers evaluating the pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of various biomarkers (e.g., IL-10, GM-CSF, MDC, with and without ex vivo lipopolysaccharide (LPS) stimulation) as markers of macrolide anti-inflammatory activity. Part A is a randomized, open-label parallel group study evaluating PK/PD of a single azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory conditions). This information will guide the range of doses to be studied in a FTIH study of a new chemical entity. Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day for 3 weeks), the dose approximates that used in the treatment of chronic neutrophil related inflammatory conditions. This information will provide insight into whether the biomarker effects change over time on repeat dosing and any potential differences observed between single and repeat doses. |
| Record Verification Date: | January 2012 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | March 2011 |
| Study Completion Date: | May 2011 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | May 2011 |
| Primary Completion Date Type: | Actual |
| Study Design: | Cohort |
| Time Perspective: | Prospective |
| Biospecimen Retention: | None retained |
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| Study Population: | Healthy volunteers |
| Sampling Method: | Probability |
| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | 65 Year |
| Enrollment: | 20 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | yes |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
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| Backup Central Contact Phone: | |
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| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GlaxoSmithKline |
| Location and Contact Information: |
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Click to view inclusion/exclusion criteria