JPRN-jRCT2031220211
Recruiting
Phase 1
A Phase I Study to Explore the Pharmacokinetics of Clofazimine in Combination with Three Antimicrobial Drugs in Japanese Patients with Pulmonary MABC Disease - MYCAT
Ho Namkoong0 sites10 target enrollmentJuly 9, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Japanese Patients with Pulmonary MABC Disease
- Sponsor
- Ho Namkoong
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(Selection criteria to be confirmed at the time of obtaining consent)
- •When obtaining consent, the investigator shall confirm the following 1\) to 7\) from the medical record, and confirm that the subject is able or willing to comply with 8\) and 9\).
- •1\) The subject has obtained written consent from the patient himself/herself to participate in this clinical trial.
- •2\) Japanese\* patients with pulmonary MABC who meet the diagnostic criteria of the 2020 ATS/ERS/ESCMID/IDSA guideline.
- •\*Japanese means the person/parents are Japanese nationals and the maternal and paternal grandparents are Japanese nationals.
- •3\) Patients whose age at the time of obtaining consent is between 20 and 85 years old
- •4\) Patients with clinical symptoms (sputum, cough, hemoptysis, chest pain, shortness of breath, fatigue, fever, night sweats, anorexia, weight loss, etc.) due to pulmonary MABC disease at the time of obtaining consent
- •5\) Patients with imaging findings (bronchiectasis, granular shadows, small nodular shadows, cavernous lesions, infiltrative shadows, etc. on chest CT) due to pulmonary MABCS. Imaging findings should be confirmed by imaging taken within 6 months prior to the start of screening.
- •6\) Must be able to take the study medication for the duration of the clinical trial.
- •7\) No history of antimicrobial agents with antimicrobial activity against pulmonary MABC disease within 4 weeks prior to the start of screening
Exclusion Criteria
- •1\) Patients with a history of oral administration of clofazimine
- •2\) Patients with a history of hypersensitivity to Lampren, clarithromycin, amikacin, or any component of imipenem hydrate or cilastatin sodium
- •3\) Patients receiving drugs contraindicated in the most recent clarithromycin package insert including pimozide, ergotamine tartrate/caffeine anhydrous, isopropylantipirine, suvorexant, lomitapide mesylate, tadalafil(adcirca), ticagrelor, ibrutinib, ibabradine hydrochloride, venetoclax (in the dose escalation phase of relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma) during the dose\-escalation phase), lurasidone hydrochloride, and anamorelin hydrochloride (contraindication to clarithromycin), etc.
- •4\) Patients with hepatic or renal impairment who are receiving colchicine (contraindication to clarithromycin)
- •5\) Patients with a history of hypersensitivity to aminoglycoside antibiotics or bacitracin (contraindication to amikacin)
- •6\) Patients with hearing loss or other hearing impairment due to aminoglycoside antibiotics in the patient or a blood relative (contraindication to Amikacin in principle)
- •7\) Patients receiving sodium valproate (contraindication to imipenem hydrate and cilastatin sodium)
- •8\) Patients at risk of the following QT interval prolongation
- •(1\) Patients with a history of torsade de pointe or other risk factors for heart failure
- •(2\) Patients with hypokalemia requiring clinical consideration of treatment
Outcomes
Primary Outcomes
Not specified
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