Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following single doses of faropenem plus amoxicillin/clavulanic acid.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; beta-Lactams; Clavulanic Acid; Clavulanic Acids; Rifampin

Criteria

Inclusion Criteria:

1. Aged 21 and above

2. Male or female willing to comply with the study visits and procedures

3. Willing and able to provide written informed consent

Exclusion Criteria:

1. Women who are currently pregnant or breastfeeding

2. Signs of active TB

3. Previous hypersensitivity or allergy to rifampicin, faropenem or other beta-lactam drugs (penicillins, carbapenems)

4. Current use of any drugs or medications known to have an interaction with any of the study drugs

5. Current use of any other drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes

6. Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations

7. Known hepatic disease or alcohol abuse

8. Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial

9. Current participation in other clinical intervention trial or research protocol