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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-02-23

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPR720

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

Group Type EXPERIMENTAL

SPR720

Intervention Type DRUG

SPR720 1000 mg (250 mg\*4 capsules) will be administered orally.

Interventions

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SPR720

SPR720 1000 mg (250 mg\*4 capsules) will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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).

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes