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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.

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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

FieldValue
Enrollment Target 39 participants
Start Date 2019-12-06
Est. Completion 2020-09-11
Phase Phase 1

Sponsor

Spero Therapeutics

14 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.