To evaluate the intrapulmonary pharmacokinetics (PK), including epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations, of SPR206 as well as plasma concentrations of SPR206 in healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
34
Three 100 mg SPR206 intravenous doses administered every 8 hours
Medical Facility
Manchester, United Kingdom
Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) for ELF, AM, and plasma
Time frame: 8 hours after the start of the third study drug IV infusion
Maximum observed concentration (Cmax) for ELF, AM, and plasma
Time frame: 8 hours after the start of the third study drug IV infusion
Minimum concentration (Cmin) for ELF, AM, and plasma
Time frame: 8 hours after the start of the third study drug IV infusion
Time to the maximum observed concentration (Tmax) for ELF, AM, and plasma
Time frame: 8 hours after the start of the third study drug IV infusion
Incidence of Treatment-Emergent Adverse Events
To assess the incidents of treatment-emergent adverse events following three 100mg SPR206 intravenous doses administered every 8 hours. AEs will be classified by System Organ Class (SOC) and Preferred Term (PT). Incidence, frequency, severity and duration will be presented.
Time frame: Day -1 to Day 7
Incidence of abnormal vital sign assessments - blood pressure
To assess the incidents of abnormal systolic and diastolic blood pressure assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.
Time frame: Day -1 to Day 7
Incidence of abnormal vital sign assessments - body temperature
To assess the incidents of abnormal body temperature assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.
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Time frame: Day -1 to Day 7
Incidence of abnormal vital sign assessments - heart rate
To assess the incidents of abnormal heart rate assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.
Time frame: Day -1 to Day 7
Incidence of abnormal vital sign assessments - respiratory rate
To assess the incidents of abnormal respiratory rate assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented.
Time frame: Day -1 to Day 7
Incidence of abnormal physical exam assessments
To assess the incidents of abnormal body system assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Changes from baseline in physical examination findings will be classified as Normal, Abnormal NCS, and Abnormal CS. Frequency counts will be presented.
Time frame: Day -1 to Day 7
Incidence of abnormal ECG assessments - heart rate
To assess the incidents of abnormal heart rate assessment following three 100mg SPR206 intravenous doses administered every 8 hours. Cardiac (12-Lead ECG) for heart rate will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.
Time frame: Day -1 to Day 7
Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval
To assess the incidents of abnormal PR interval, RR interval, QRS interval, QT interval and QTcF interval assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Cardiac (12-Lead ECG) results will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.
Time frame: Day -1 to Day 7
Incidence of abnormal safety laboratory assessments
To assess the incidents of abnormal hematology, serum chemistry, coagulation and urinalysis assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency counts of significant changes from baseline will be presented.
Time frame: Day -1 to Day 7