Effect of probenecid or ibuprofen on flucloxacillin exposure in healthy adults

Phase 4

Completed

• Conditions: Methicillin-susceptible Staphylococcus aureus (MSSA) infection; Other infections require flucloxacillin for treatment; Infection - Other infectious diseases

• Registration Number: ACTRN12623001155684
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-08
• Study Completion: 2024-02-07
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Body mass index (BMI) of 18.0 – 32.0 kg/m2 and body weight >= 50.0 kg.
2. Medically healthy, determined by medical history, physical examination, non-clinically significant laboratory profiles, vital signs, and 12-lead ECG at screening, as deemed by the Investigator.
3. Females must be non-pregnant, non-lactating, or postmenopausal for at least 1 year or surgically sterile for at least 6 months prior to dosing.
4. If relevant, non-pregnant female participants will be required to use an effective form of contraception from 28 days prior to the study until the end of study.
5. Males must not have a pregnant partner and must agree to use condoms as a method of contraception from the time of signing informed consent until the end of study.

Exclusion Criteria

1. History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
2. Significant history of hospitalization for illness within the six months prior to enrolment into the study, or major surgery within the 12 months prior to enrolment into the study, as assessed by the study physician or investigator.
3. A contraindication or significant risk associated with the use of either of IMPs.
4. Likely to have altered drug exposures.
5. Other health risks as determined by the study physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified