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NCT04178577 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function
A Phase 1 study, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT04178577: Completed Phase 1 study, sponsored by Spero Therapeutics.
NCT04178577 is a Phase 1 study that has completed, run by Spero Therapeutics. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04178577, a Phase 1 study, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
Evaluation of the pharmacokinetics (PK) of TBPM-PI-HBr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.
Interventions
- DRUG Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-12-06 |
| Est. Completion | 2020-09-11 |
| Phase | Phase 1 |
What the finished NCT04178577 record still lists
NCT04178577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) is the first listed.
NCT04178577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04178577 about?
NCT04178577 is a clinical study titled "Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function". Evaluation of the pharmacokinetics (PK) of TBPM-PI-HBr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.
What is the current status of trial NCT04178577?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2019-12-06. Estimated completion is 2020-09-11.
What interventions are being tested in trial NCT04178577?
The interventions under investigation include: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) (DRUG).
Who is sponsoring clinical trial NCT04178577?
This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04178577's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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