NCT05955586

A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Oral Administration of Multiple Doses of SPR720 in Healthy Volunteers.

A Phase 1, Single-center, Open-label Study to Assess the Intrapulmonary Pharmacokinetics of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Oral Administration of Multiple Doses of SPR720 in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	SPR720	SPR720 1000 mg (250 mg\*4 capsules) will be administered orally.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-02-09
• Completion: 2024-02-23
• First posted: 2023-07-21
• Last updated: 2024-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study