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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 is a Phase 1 study that has completed, run by Spero Therapeutics. The registered enrollment target is 39 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04178577
The ClinicalTrials.gov registry entry for NCT04178577 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spero Therapeutics, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) is the first listed.
NCT04178577 reports 0 study locations.
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.
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