Pharmacokinetic Study of Minocycline in Patients With Pulmonary Nontuberculous Mycobacterial Disease
Status:
Not yet recruiting
Trial end date:
2024-09-22
Target enrollment:
Participant gender:
Summary
Antimycobacterial treatment of M. avium complex pulmonary disease (MAC-PD) has suboptimal
cure rates and is challenging due to frequent adverse drug reactions and drug-drug
interactions. Hence, there is an urgent need for improved treatment regimens with effective
and tolerable antibiotics.
Minocycline is a well-tolerated, orally administered tetracycline-type antibiotic with in
vitro activity against MAC, but pharmacokinetic data in the target population is lacking.
Moreover, rifampicin, a strong inducer of cytochrome P450 enzymes involved in drug metabolism
and of various drug transporters, is part of the current first-line MAC-PD treatment regimen
and has a substantial interaction with doxycycline, a related tetracycline.
Pharmacokinetic data in the target population will allow us to propose an appropriate dose of
minocycline when co-administered with or without rifampicin
Mino-PK is an open label, one-arm, two-period, fixed-order pharmacokinetic study that will
assess exposure to minocycline in MAC-PD patients with and without concurrent use of
rifampicin. Subjects will receive two 5-day dosing periods of minocycline; the first without
and second with concurrent use of rifampicin. Minocycline plasma concentrations will be
determined after both dosing periods.