Completed PHASE1 INTERVENTIONAL 1-arm NCT04178577

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, Open-Label Study to Assess the Pharmacokinetics and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees of Renal Function

Sponsor: Spero Therapeutics

Conditions Renal Impairment

Interventions Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)

Updated 6 times since 2019 Last updated: Nov 24, 2020 Started: Dec 6, 2019 Primary completion: Sep 6, 2020 Completion: Sep 11, 2020

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Renal Impairment and is currently completed. Spero Therapeutics leads this study, which shows 6 recorded versions since 2019 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Dec 2020 — Jan 2021 [monthly]

Completed PHASE1

Status: Recruiting → Completed
Feb 2020 — Dec 2020 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting

▶ Show 1 earlier version

Dec 2019 — Feb 2020 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Spero Therapeutics

Data source: Spero Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Miami, United States
• Orlando, United States