To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
Capsules for oral administration
Capsules for oral administration
Standard of Care regimen is at the Investigator's discretion; recommended 2-drug or 3-drug SOC, consisting of either: * Clarithromycin 500-1000 mg, plus ethambutol hydrochloride (HCl) 15 mg/kg orally once daily or * Azithromycin 250-500 mg plus ethambutol HCl 15 mg/kg orally once daily. Optional rifampin 600 mg or rifabutin 300 mg orally once daily may be added to the SOC regimen for up to 28 days.
Medical Facility
Altamonte Springs, Florida, United States
Medical Facility
Atlantis, Florida, United States
Medical Facility
Clearwater, Florida, United States
Medical Facility
Kissimmee, Florida, United States
Maximum Plasma Concentration (Cmax) of SPR719
SPR719 is the active moiety of the prodrug SPR720. Blood samples were planned to be taken at a subset of study sites in order to conduct intensive pharmacokinetic (PK) evaluation.
Time frame: Day 1 and Day 28 pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of SPR719
Time frame: Day 1 and Day 28 pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose
Area Under the Concentration-time Curve From Zero to Tau, Where Tau is the Dosing Interval (AUC0-tau) for SPR719
Time frame: Day 1 and Day 28 pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose
Accumulation Ratio of SPR719
Time frame: Day 1 and Day 28 pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether related to this product or not. This includes any newly occurring event or previous condition that has increased in severity or frequency since starting active or randomized treatment. The Investigator assessed the intensity for each AE reported during the study using the latest version of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, as Mild, Moderate, Severe, Life-threatening, or Death.
Time frame: From first dose of study drug (Day 1) up to 28 days after last dose (56 days)
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Medical Facility
West Palm Beach, Florida, United States
Medical Facility
Charlotte, North Carolina, United States
Medical Facility
Mooresville, North Carolina, United States
Medical Facility
Winston-Salem, North Carolina, United States
Medical Facility
Pittsburgh, Pennsylvania, United States
Number of Participants With Clinically Meaningful Change in Physical Examination Findings
Full physical examination were conducted on Day 1 and 28 days after last dose (Day 56) and included, at a minimum, assessment of the following systems: skin, head, ears, eyes, nose and throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system. Symptom-directed physical examinations were conducted at study visits on Days 7, 14, 21, and 28.
Time frame: Days 1, 7, 14, 21, 28, and 56
Number of Participants Who Received Any Concomitant Medication During the Study
Time frame: Day 1 to Day 56
Changes From Baseline in Laboratory Tests
Time frame: Days 1, 7, 14, 21, 28, and 56
Number of Participants With Clinically Significant Out-of-normal Range Laboratory Tests
Clinical laboratory tests included serum chemistry, hematology, coagulation tests, and urinalysis. The investigator determined whether any changes in laboratory values were clinically significant based on the condition of the participant and the extent and duration of the deviation from the reference range.
Time frame: Days 1, 7, 14, 21, 28, and 56
Shifts From Baseline in Selected Laboratory Tests Using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Shift Categories
Time frame: Days 1, 7, 14, 21, 28, and 56
Changes From Baseline in Vital Sign Measurements
Vital signs measurements included systolic and diastolic blood pressure, pulse, temperature, and respiratory rate.
Time frame: Days 1, 7, 14, 21, 28, and 56
Number of Participants With Clinically Significant Abnormal Electrocardiogram Findings
Standard 12-lead electrocardiogram (ECG) assessments included heart rate, cardiac rhythm, PR interval, RR interval, QRS interval, QT interval and QTC interval. Clinical significance was determined by the investigator.
Time frame: Days 1, 14, 28, and 56