A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants

ClinicalTrials.gov ID: NCT06727136

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Official title

A Phase 1, Open-label Study to Characterize Single and Repeat Dose Pharmacokinetics (Including Food Effect) of Tebipenem-pivoxil-hydrobromide and Its Major Metabolite (SPR1349) in Healthy Participants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.

Study identification

NCT ID: NCT06727136
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Spero Therapeutics; Industry
Enrollment: 39 participants

Conditions and interventions

Conditions

Healthy Participants

Interventions

TBP-PI-HBr Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 20, 2024 (Actual)
Primary completion: Apr 22, 2025 (Actual)
Completion: Apr 22, 2025 (Actual)
Last update posted: May 20, 2025

2024 – 2025

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Medical Facility, Salt Lake City	Salt Lake City	Utah	84124	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06727136, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 20, 2025 · Synced Nov 15, 2026