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.

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: SPR720

• Registration Number: NCT05955586
• Lead Sponsor: Spero Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Study Start: 2023-08-01
• Primary Completion: 2024-02-09
• Study Completion: 2024-02-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPR720	SPR720	Healthy participants will receive SPR720 1000 mg capsule, orally, for 7 days.

Primary Outcome Measures

Name	Time	Method
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
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
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

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From first dose of study drug until the follow-up visit (up to 15 days)

Trial Locations

Locations (1)

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States