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NCT04710407 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04710407 is a Phase 1 study of Healthy Volunteers that has completed, run by Spero Therapeutics. The registered enrollment target is 30 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04710407, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.
Conditions Studied
Interventions
- DRUG TBPM-PI-HBr
Study Locations (1)
Arizona
- Pulmonary Associates - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2021-03-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04710407
The ClinicalTrials.gov registry entry for NCT04710407 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower). The listed sponsor is Spero Therapeutics, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which TBPM-PI-HBr is the first listed.
NCT04710407 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT04710407 about?
NCT04710407 is a clinical study titled "Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers". To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.
What is the current status of trial NCT04710407?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2020-12-07. Estimated completion is 2021-03-10.
What conditions does trial NCT04710407 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04710407?
The interventions under investigation include: TBPM-PI-HBr (DRUG).
Who is sponsoring clinical trial NCT04710407?
This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04710407 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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