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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: Completed Phase 1 study of Healthy Volunteers, sponsored by Spero Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary PK outcome endpoints following oral administration of \[14C\]-TBPM-PI-HBr will be derived for TBPM in plasma (calculated from whole blood concentrations) based on the concentration-time profile
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 |
What the finished NCT04625855 record still lists
NCT04625855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04625855's enrollment target sits among peer trials
8 269th of 283 higher than 7 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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