Status:
COMPLETED
A Single and Repeat Dose PK/PD Study to Characterise Biomarker Response in Healthy Subjects Treated With Azithromycin
Lead Sponsor:
GlaxoSmithKline
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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., I...
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., I...
Eligibility Criteria
Inclusion
- Male or female between 18 and 65 years of age inclusive
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy
- Child-bearing potential and agrees to use one of the contraception methods
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18.5 - 30 kg/m2 (inclusive)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions
- Single QT duration corrected for heart rate by Bazett's formula (QTcB) \< 450 msec.
Exclusion
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- A positive pre-study drug/alcohol screen
- A positive test for HIV antibody
- History of regular alcohol consumption within 6 months of the study
- The subject has participated in a clinical trial and has received an investigational product within the 3 months
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements
- History of sensitivity to any of the study medications, or erythromycin, any macrolide or ketolide antibiotic
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
- The subject has donated blood in the 3 months prior to the study
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing
- Lactating females
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
Key Trial Info
Start Date :
March 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01416350
Start Date
March 30 2011
End Date
May 12 2011
Last Update
July 21 2017
Active Locations (1)
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1
GSK Investigational Site
London, United Kingdom, NW10 7EW