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| Name | Class |
|---|---|
| Clinartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBPM-PI-HBr | Experimental | Healthy subjects meeting eligibility criteria will receive a total of five doses of TBPM-PI-HBr 600 mg orally every 8 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBPM-PI-HBr | Drug | TBPM-PI-HBr (2 x 300mg tablets) a total of five doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Day 1 to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, including adverse events (AEs) | Frequency of adverse events by severity, seriouness, system organ class, preferred term and treatment group | Day 1 to Day 10 |
| Safety and tolerability, including clinically significant changes from baseline in clinical laboratory values |
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Inclusion Criteria:
Exclusion Criteria:
History of seizure disorders
Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)
Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV);
Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;
Presence of the following symptoms at screening or within 14 days prior to screening or Check-in (Day -1)
Close contact with anyone who tested positive for SARS-CoV-2 infection within 14 days prior to screening or Check-in (Day -1);
Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females
Subjects who have any of the following abnormalities on laboratory values at screening or prior confinement including:
History of substance abuse or alcohol abuse
Use of tobacco/nicotine- or marijuana-containing products (including vaping products) within 12 months prior to screening;
Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
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| Name | Affiliation | Role |
|---|---|---|
| David Baratz, MD | Pulmonary Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Phoenix | Arizona | 85032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35762796 | Derived | Rodvold KA, Gotfried MH, Gupta V, Ek A, Srivastava P, Talley A, Bruss J. Plasma and Intrapulmonary Concentrations of Tebipenem following Oral Administration of Tebipenem Pivoxil Hydrobromide to Healthy Adult Subjects. Antimicrob Agents Chemother. 2022 Jul 19;66(7):e0059022. doi: 10.1128/aac.00590-22. Epub 2022 Jun 28. |
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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 |
| Day 1 to Day 10 |
| Safety and tolerability, including physical examination | Change from baseline in vital signs | 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 | Day 1 to Day 10 |
| ID | Term |
|---|---|
| C500135 | tebipenem |
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