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.

Healthy Volunteer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05955586
• Other study ID #: SPR720-103
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2023
• Est. completion date: February 23, 2024

Study information

• Verified date: March 2024
• Source: Spero Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 23, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• SPR720
SPR720 1000 mg (250 mg*4 capsules) will be administered orally.

Locations

Country	Name	City	State
United States	Pulmonary Associates	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Spero Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of Participants With Treatment-emergent Adverse Events (TEAEs)		From first dose of study drug until the follow-up visit (up to 15 days)