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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: SPR720

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Pulmonary Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. Body mass index (BMI) ≥18.0 and ≤32.0 kilograms per meter square (kg/m^2) and weight between 55.0 and 100.0 kilograms (kg) (inclusive).
2. Forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value at screening visit.
3. Have suitable venous access for blood sampling.
4. Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food or product containing any of these from 48 hours prior to study drug administration until discharge from the clinical research unit (CRU).

Key Exclusion Criteria:

1. History of clinically significant acute illness or surgery within the previous 3 months prior to Screening Visit or Day -1.
2. Known history of clinically significant hypersensitivity reaction or anaphylaxis to SPR720 or an aminobenzimidazole.
3. Any condition possibly affecting drug absorption (e.g. previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas]).
4. Participants who are unable to demonstrate the ability to swallow the dosage forms.
5. Receipt of any other investigational medicinal product or participation in another investigational clinical study that included drug treatment within 30 days prior to Day 1 dose (based on the timing of the last Follow-up Visit in the previous study to Day 1 of the current study).

NOTE: Other inclusion and exclusion criteria as per protocol may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPR720; Healthy participants will receive SPR720 1000 mg capsule, orally, for 7 days.	Drug: SPR720; SPR720 1000 mg (250 mg*4 capsules) will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Spero Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SPR720-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No