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The primary purpose of this study is to evaluate the intrapulmonary PK, including epithelial lining fluid (ELF) and alveolar macrophages (AM) concentrations, of SPR719 compared to plasma concentrations of SPR719 (the active moiety in plasma of the prodrug SPR720) after oral administration of SPR720 1000 milligram (mg) capsules every 24 hours for 7 consecutive doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPR720 | Experimental | Healthy participants will receive SPR720 1000 mg capsule, orally, for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPR720 | Drug | SPR720 1000 mg (250 mg*4 capsules) will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve from Time Zero to 24 Hours (AUC0-24) of SPR719 in plasma, ELF and AM | Predose on Day 6 and post-dose at multiple time points up to Day 8 | |
| Maximum Observed Concentration (Cmax) of SPR719 in plasma, ELF and AM | Predose on Day 6 and post-dose at multiple time points up to Day 8 | |
| Time to the Maximum Observed Concentration (Tmax) of SPR719 in plasma, ELF and AM | Predose on Day 6 and post-dose at multiple time points up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug until the follow-up visit (up to 15 days) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other inclusion and exclusion criteria as per protocol may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Phoenix | Arizona | 85032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39352135 | Derived | Rodvold KA, Gotfried MH, Ussery XT, Wong SL, Hamed KA. Intrapulmonary pharmacokinetics of SPR719 following oral administration of SPR720 to healthy volunteers. Antimicrob Agents Chemother. 2024 Nov 6;68(11):e0110324. doi: 10.1128/aac.01103-24. Epub 2024 Oct 1. |
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