Status:
COMPLETED
Cefixime / Azithromycin pK Study
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Gonorrhoea
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a...
Detailed Description
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a...
Eligibility Criteria
Inclusion
- 1\. Healthy male or female subjects between 18 and 45 years, inclusive 2. Ability to understand the consent process and procedures 3. Informed consent obtained and signed prior to initiation of any study procedures 4. Subjects agree to be available for all study visits 5. Negative breathalyzer for alcohol 6. Agreement by female subjects with reproductive potential to use an adequate method of contraception during the study and for 30 days after last study drug administration. Female subjects must agree to the use of TWO reliable methods of contraception while receiving study drug and for 30 days after last study drug administration if sexually active, which can include: condoms, spermicidal gel, diaphragm, hormonal or non-hormonal intrauterine device, surgical sterilization, oral contraceptive pill (OCP), and depot progesterone injections.
Exclusion
- 1\. Subjects who take any prescription medication on a regular basis (except OCPs), including but not limited to, anti-psychotics, anti-depressants, anti-epileptics, cardiac medications, and antihypertensives. 2. Subjects who take any OTC drugs or herbal remedies on a regular basis, especially those that have been associated with a risk of QT prolongation such as antiemetics (ondansetron, granisetron, dolasetron, hydroxyzine), antihistamines (terfenadine, astemizole, hydroxyzine, diphenhydramine), GI stimulants (cisapride, domperidone, metoclopramide), and homeopathic agents (cinchona, licorice extract- glycyrrhizin). 3. Hypertension with confirmed systolic blood pressure \>140 mmHg or confirmed diastolic blood pressure \> 90 mmHg, measured after 10 to 15 minutes of rest 4. Morbid obesity (BMI \>/= 35 kg/m\^2) 5. Current diagnosis of pulmonary disease 6. History or current diagnosis of diabetes 7. Autoimmune disorders, such as lupus, Wegener's, rheumatoid arthritis 8. History of malignancy except low-grade skin cancer, (i.e., basal cell carcinoma thought to be cured) 9. Known diagnosis of prolonged QT interval, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure 10. History of alcohol abuse 11. History of seizure disorder 12. History of renal disease 13. Chronic renal, hepatic, or pulmonary disease or other condition that could interfere with the absorption of the study drug or predispose to adverse GI events (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, irritable bowel syndrome, inflammatory bowel disease) 14. Positive serology results for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies 15. Subjects who have taken any prescription drugs in the previous 14 days or within five half-lives before dosing 16. Ingestion of OTC medications or herbal supplements within seven days of dosing 17. Positive urine drug screen for marijuana, cocaine, amphetamines, opiates, phencyclidine, barbiturates, or benzodiazepines 18. History of allergic reaction or intolerance to cephalosporins 19. History of allergic reaction to penicillin (all stages) 20. History of allergic reaction to azithromycin, erythromycin, or any macrolide or ketolide antibiotic 21. History of jaundice or hepatic dysfunction associated with prior use of azithromycin 22. Males with a QTcF \> 430ms or Females with a QTcF \>450ms (Fridericia's correction) on screening 23. Positive pregnancy test; pregnant or nursing women 24. Screening laboratory tests \> Grade 1 as defined by Appendix B 25. Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety.
Key Trial Info
Start Date :
April 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02708992
Start Date
April 28 2016
End Date
July 31 2017
Last Update
September 15 2017
Active Locations (1)
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1
Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit
Durham, North Carolina, United States, 27710-4000