Pharmacokinetic Study of Minocycline in Patients With Pulmonary Nontuberculous Mycobacterial Disease

Last updated: June 25, 2025
Sponsor: Radboud University Medical Center
Overall Status: Terminated

Phase

2

Condition

Mac Infection (Mycobacterium Avium Complex)

Treatment

Minocycline

Clinical Study ID

NCT05861258
NL69313.091.19
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 2020 guideline (ATS/ERS/ESCMID/IDSA) diagnostic criteria for nontuberculousmycobacterial pulmonary disease are met, i.e. the patient is symptomatic, hasnodules, bronchiectasis or fibro-cavitary lesions seen on (HR)CT scan of the lungsand ≥2 positive sputum cultures or one positive bronchoalveolar lavage culture ofthe same M. avium complex species.

  • At least one of the positive cultures must be done in the last 4 months beforeinclusion.

  • The subject is eligible to start the guideline-recommended rifampicin-based regimenaccording to the treating physician.

  • Age ≥ 18 years.

  • Signed and dated patient informed consent.

Exclusion

Exclusion Criteria:

  • A relevant medical history or current condition that might interfere with drugabsorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinaldisease, renal or hepatic disease).

  • Diagnosed with cystic fibrosis (as this may affect the pharmacokinetics of drugs).

  • Pregnant or breastfeeding (contra-indications for minocycline) or inadequatecontraceptive measures (in view of the administration of rifampicin which interactswith oral contraceptive drugs, adequate contraceptive measures are abstinence fromsexual activities and barrier methods).

  • Use of drugs that cause a relevant drug interaction with minocycline, i.e. oralmagnesium, , bismuth, aluminium, calcium, zinc or iron containing formulations,antacid drugs and drugs besides rifampicin that are strong inducers of metabolicenzymes, including barbiturates, carbamazepin and phenytoin (as judged by theinvestigators).

  • ALAT > 3 times the upper limit of normal (normal <45 U/l).

  • ASAT > 3 times the upper limit of normal (normal <35 U/l).

  • An abnormal serum creatinine level (defined as a level that is higher than the upperlimit of normal, i.e. >110 umol/l).

  • Active alcohol abuse.

  • Hypersensitivity to minocycline or to other tetracycline antibiotics.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Minocycline
Phase: 2
Study Start date:
May 08, 2023
Estimated Completion Date:
June 11, 2025

Connect with a study center

  • Radboud University Medical Center

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Site Not Available

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