Status:
COMPLETED
Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease
Lead Sponsor:
Radboud University Medical Center
Conditions:
Nontuberculous Mycobacterial Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Clofazimine (CFZ) is a promising drug for the treatment of NTM diseases. CFZ is highly active in vitro against M. abscessus and M. avium, the most common NTM pathogens, and shows synergy with macrolid...
Eligibility Criteria
Inclusion
- The participant is diagnosed with pulmonary or extrapulmonary NTM disease and is eligible for treatment with CFZ
- The participant is at least 18 years of age
- The participant has a body weight (in light clothing and with no shoes) of at least 45 kg
- The participant is able and willing to provide written, informed consent
Exclusion
- The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
- There is evidence showing the participant has clinically significant metabolic, gastrointestinal, or other abnormalities that could possibly alter the PK of CFZ
- The participant is diagnosed with cystic fibrosis
- The participant has a prolongation of the QTc interval, \> 450 milliseconds for males and \> 460 milliseconds for females, on the screening ECG
- The participant has abnormal alanine aminotransferase (ALT) and/or aspartate transferase (AST) levels of \> 3 times the upper limit of the laboratory reference range at screening
- The participant is pregnant or is using inadequate contraceptive measures (if applicable)
- The participant is breastfeeding (if applicable)
- The participant has a known or suspected, current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient
- The participant has as history of allergy/hypersensitivity to CFZ
- The participant has received clofazimine in the past 3 months before inclusion with the exception of short-term use of no more than 7 days in the period of 1 to 3 months before inclusion
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05294146
Start Date
February 14 2022
End Date
August 8 2023
Last Update
August 16 2023
Active Locations (1)
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1
Radboud university medical center
Nijmegen, Gelderland, Netherlands, 6525 GA