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NCT04625855 · ClinicalTrials.gov registry record · Phase 1
Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects
A Phase 1 study of Healthy Volunteers, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04625855 is a Phase 1 study of Healthy Volunteers that has completed, run by Spero Therapeutics. The registered enrollment target is 8 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04625855, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the absorption, metabolism, and excretion of \[14C\]-TBPM-PI-HBr and to characterize and determine the metabolites present in plasma, urine, and where possible, feces in healthy male subjects following a single oral administration.
Conditions Studied
Interventions
- DRUG TBPM-PI-HBr
Study Locations (1)
Wisconsin
- Covance Clinical Research Unit, Inc. - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2020-10-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04625855
The ClinicalTrials.gov registry entry for NCT04625855 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 (98% 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.
NCT04625855 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04625855 about?
NCT04625855 is a clinical study titled "Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects". The purpose of this study is to determine the absorption, metabolism, and excretion of \[14C\]-TBPM-PI-HBr and to characterize and determine the metabolites present in plasma, urine, and where possible, feces in healthy male subjects following a single oral administration.
What is the current status of trial NCT04625855?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2020-09-30. Estimated completion is 2020-10-16.
What conditions does trial NCT04625855 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04625855?
The interventions under investigation include: TBPM-PI-HBr (DRUG).
Who is sponsoring clinical trial NCT04625855?
This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04625855 being conducted?
This trial has 1 study location across Wisconsin. 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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