Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

February 14, 2022

Primary Completion Date

May 1, 2023

Study Completion Date

August 8, 2023

Conditions
Nontuberculous Mycobacterial Diseases
Interventions
DRUG

Clofazimine

"All participants will receive an (experimental) oral loading dose regimen of 300 mg clofazimine once daily (= 3 capsules of 100 mg) for 4 weeks. Afterwards, all participants will continue with a standard oral dose of 100 mg clofazimine once daily (= 1 capsule of 100 mg) until a total 4 months of treatment with CFZ.~Blood samples will be taken at Day 28 (+/- 2 days), Day 29 (Day 28 +1) and after 4 months of treatment to assess the pharmacokinetics of CFZ, both with the loading dose and the standard dose. In addition, the safety/tolerability of CFZ will monitored."

Trial Locations (1)

6525 GA

Radboud university medical center, Nijmegen

All Listed Sponsors
lead

Radboud University Medical Center

OTHER