Pharmacokinetic Study of Minocycline in Patients With Pulmonary Nontuberculous Mycobacterial Disease (Mino-PK)

NCT05861258 PHASE2 TERMINATED

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.

Details

Lead sponsor	Radboud University Medical Center
Phase	PHASE2
Status	TERMINATED
Enrolment	12
Start date	Mon May 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jun 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Mycobacterium Avium Complex Pulmonary Disease

Interventions

• Minocycline

Countries

Netherlands