To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
TBPM-PI-HBr (2 x 300mg tablets) a total of five doses
Pulmonary Associates
Phoenix, Arizona, United States
Plasma PK and lung penetration of SPR859 following multiple doses
Plasma PK parameters will include the area under the curve (AUC) from time zero to the last quantifiable sample (AUC0-t), AUC from time zero to end of dosing interval (AUC0-8). The AUC0-8 values for ELF and AM will be determined. The ratios of the AUC0-8 of ELF to the AUC0-8 of plasma and the AUC0-8 of AM to the AUC0-8 of plasma will be calculated.
Time frame: Day 1 to Day 3
Plasma PK and lung penetration of SPR859 following multiple doses
Plasma PK parameters will include the maximum concentration (Cmax), minimum concentration (Cmin), time to Cmax (tmax), and the terminal-phase half-life (t1/2).
Time frame: Day 1 to Day 3
Safety and tolerability, including adverse events (AEs)
Frequency of adverse events by severity, seriouness, system organ class, preferred term and treatment group
Time frame: Day 1 to Day 10
Safety and tolerability, including clinically significant changes from baseline in clinical laboratory values
Change from baseline in selected laboratory assays including WBC, hemoglobin, platelet count, liver function tests (AST, ALT, AP), blood urea nitrogen (BUN), serum creatinine (Cr), and estimated Cr clearance (based on Cockcroft-Gault formula), by treatment group
Time frame: Day 1 to Day 10
Safety and tolerability, including physical examination
Change from baseline in vital signs
Time frame: Day 1 to Day 10
Safety and tolerability, including ECG
Cardiac (12-Lead ECG) will be summarized at each scheduled time point using descriptive statistics
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Time frame: Day 1 to Day 10