ClinicalTrials.gg
CompletedNCT05955586Updated Mar 7, 2024

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 interventional study of SPR720 in Healthy Volunteer, sponsored by Spero Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Spero Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2024, 2 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Spero Therapeutics is the lead sponsor of 22 studies on the registry; none are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 3 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. (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. (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 acute illness or surgery within the previous 3 months prior to Screening Visit or Day -1.
  2. Known history of clinically significant 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 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.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    SPR720

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

    Drug: SPR720

Interventions

  • DrugSPR720

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

06

What researchers measure

Primary outcomes

  1. Area Under the Concentration-time Curve from Time Zero to 24 Hours (AUC0-24) of SPR719 in plasma, ELF and AM

    Time frame: Predose on Day 6 and post-dose at multiple time points up to Day 8

  2. Maximum Observed Concentration (Cmax) of SPR719 in plasma, ELF and AM

    Time frame: Predose on Day 6 and post-dose at multiple time points up to Day 8

  3. Time to the Maximum Observed Concentration (Tmax) of SPR719 in plasma, ELF and AM

    Time frame: Predose on Day 6 and post-dose at multiple time points up to Day 8

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: From first dose of study drug until the follow-up visit (up to 15 days)

07

Study locations

1 site
  • Pulmonary Associates
    Phoenix, Arizona 85032, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05955586
Lead sponsor
Spero Therapeutics
Responsible party
Sponsor
First posted
Jul 21, 2023
Start date
Aug 1, 2023
Primary completion
Feb 9, 2024
Completion
Feb 23, 2024
Last update
Mar 7, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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