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Mycobacterium Avium Complex Pulmonary DiseasePhase 2Mino-PKNCT05861258

Pharmacokinetic Study of Minocycline in Patients With Pulmonary Nontuberculous Mycobacterial Disease

A Phase 2 study testing Minocycline in people with Mycobacterium Avium Complex Pulmonary Disease, run by Radboud University Medical Center at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Minocycline
How many people
12 participants
Where
1 siteNetherlands
Study dates
8 May 2023to 11 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 2020 guideline (ATS/ERS/ESCMID/IDSA) diagnostic criteria for nontuberculous mycobacterial pulmonary disease are met, i.e. the patient is symptomatic, has nodules, bronchiectasis or fibro-cavitary lesions seen on (HR)CT scan of the lungs and ≥2 positive sputum cultures or one positive bronchoalveolar lavage culture of the same M. avium complex species.
  • At least one of the positive cultures must be done in the last 4 months before inclusion.
  • The subject is eligible to start the guideline-recommended rifampicin-based regimen according to the treating physician.
  • Age ≥ 18 years.
  • Signed and dated patient informed consent.

Who cannot join

  • A relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinal disease, renal or hepatic disease).
  • Diagnosed with cystic fibrosis (as this may affect the pharmacokinetics of drugs).
  • Pregnant or breastfeeding (contra-indications for minocycline) or inadequate contraceptive measures (in view of the administration of rifampicin which interacts with oral contraceptive drugs, adequate contraceptive measures are abstinence from sexual activities and barrier methods).
  • Use of drugs that cause a relevant drug interaction with minocycline, i.e. oral magnesium, , bismuth, aluminium, calcium, zinc or iron containing formulations, antacid drugs and drugs besides rifampicin that are strong inducers of metabolic enzymes, including barbiturates, carbamazepin and phenytoin (as judged by the investigators).
  • ALAT > 3 times the upper limit of normal (normal <45 U/l).
  • ASAT > 3 times the upper limit of normal (normal <35 U/l).
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  • An abnormal serum creatinine level (defined as a level that is higher than the upper limit of normal, i.e. >110 umol/l).
  • Active alcohol abuse.
  • Hypersensitivity to minocycline or to other tetracycline antibiotics.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

About this study

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.

Read more

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.

Being tested
Minocycline
Keywords
Pharmacokinetics, Minocycline, Rifampicin
Medical subject headings
cyclopia sequence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MinocyclineDrug

    Patients with M. avium complex pulmonary disease will receive 200 mg of minocycline for 5 days before starting rifampicin and after 1 month (±1 week) of receiving rifampicin. Antimycobacterial drugs other than rifampicin can be started prior to or simultaneous with the first minocycline dosing period as part of standard care. At day 5 of both minocycline dosing periods, blood will be sampled for minocycline plasma concentration measurements at T = 0, 1, 2, 3, 4, 6, 8 and 24 hours.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic parameters of minocycline in MAC-PD patients without concurrent use of rifampicin.

    The area under the curve (AUC0-24h)

    Measured: Day 5 of the first minocycline dosing period

  2. Pharmacokinetic parameters of minocycline in MAC-PD patients without concurrent use of rifampicin.

    The peak plasma concentration (Cmax)

    Measured: Day 5 of the first minocycline dosing period

  3. Pharmacokinetic parameters of minocycline in MAC-PD patients without concurrent use of rifampicin.

    The plasma trough concentration (Cmin)

    Measured: Day 5 of the first minocycline dosing period

Secondary outcomes (5)

  1. Pharmacokinetic parameters of minocycline in MAC-PD patients with concurrent use of rifampicin.

    The area under the curve (AUC0-24h)

    Measured: Day 5 of the second minocycline dosing period

  2. Pharmacokinetic parameters of minocycline in MAC-PD patients with concurrent use of rifampicin.

    The peak plasma concentration (Cmax)

    Measured: Day 5 of the second minocycline dosing period

  3. Pharmacokinetic parameters of minocycline in MAC-PD patients with concurrent use of rifampicin.

    The plasma trough concentration (Cmin)

    Measured: Day 5 of the second minocycline dosing period

  4. Pharmacokinetic parameters of rifampicin in MAC-PD patients

    The peak plasma concentration (Cmax)

    Measured: Day 5 of the second minocycline dosing period

  5. Adverse Events

    The number of (participants with) adverse events will be measured. Adverse events will be graded according to the 'Common Terminology Criteria for Adverse Events' (CTCAE)

    Measured: Through study completion, an average of 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2023
  2. Study start8 May 2023
  3. Primary completion14 May 2025
  4. Study completion11 Jun 2025

Why it stopped: The trial was terminated prematurely after the enrollment of 12 out of 15 planned subjects, due to a lack of personnel and no option to continue study measurements.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single group, two-period, fixed-order pharmacokinetic study
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05861258
Sponsor's protocol ID
NL69313.091.19
Acronym
Mino-PK
Status last verified
Nov 2024
First submitted
4 May 2023
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The pseudonymized participant data will be accessible in the Radboud Data Repository under restricted access, only if the participant has provided consent. Requests for access will be checked, by a data access committee (DAC) formed by the sponsor (i.e. PI and other research members / coordinators) The following data will be shared: * Final versions of data used for analysis * Documentation/codebooks necessary for understanding the data * The .xml file that contains the full structure of the eCRF build in Castor EDC * Read me.txt for understanding the structure and content of the documents

Publications

  • Daley CL, Iaccarino JM, Lange C, Cambau E, Wallace RJ Jr, Andrejak C, Bottger EC, Brozek J, Griffith DE, Guglielmetti L, Huitt GA, Knight SL, Leitman P, Marras TK, Olivier KN, Santin M, Stout JE, Tortoli E, van Ingen J, Wagner D, Winthrop KL. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Eur Respir J. 2020 Jul 7;56(1):2000535. doi: 10.1183/13993003.00535-2020. Print 2020 Jul.

    PubMed 32636299

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Minocycline in people with Mycobacterium Avium Complex Pulmonary Disease, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial was terminated prematurely after the enrollment of 12 out of 15 planned subjects, due to a lack of personnel and no option to continue study measurements.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameters of minocycline in MAC-PD patients without concurrent use of rifampicin. (time frame: Day 5 of the first minocycline dosing period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05861258, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

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