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OpenTrials
Completed

NCT Number: NCT05955586

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.

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pulmonary Associates

Phoenix, Arizona, 85032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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).
  • Forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value at screening visit.
  • Have suitable venous access for blood sampling.
  • 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:

  • History of clinically significant acute illness or surgery within the previous 3 months prior to Screening Visit or Day -1.
  • Known history of clinically significant hypersensitivity reaction or anaphylaxis to SPR720 or an aminobenzimidazole.
  • 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]).
  • Participants who are unable to demonstrate the ability to swallow the dosage forms.
  • 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.

Treatment and study plan

SPR720

Drug

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

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)

Sponsors and collaborators

Lead sponsor

Spero Therapeutics

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2023
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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