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NCT06727136 · ClinicalTrials.gov registry record · Phase 1
A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants
A Phase 1 study of Healthy Participants, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT06727136 is a Phase 1 study of Healthy Participants that has completed, run by Spero Therapeutics. The registered enrollment target is 39 participants, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06727136, a Phase 1 study of Healthy Participants, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG TBP-PI-HBr
Study Locations (1)
Utah
- Medical Facility, Salt Lake City - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2024-11-20 |
| Est. Completion | 2025-04-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06727136
The ClinicalTrials.gov registry entry for NCT06727136 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, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (40% lower). The listed sponsor is Spero Therapeutics, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Participants appearing as the primary indexed condition, and to 1 intervention - of which TBP-PI-HBr is the first listed.
NCT06727136 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT06727136 about?
NCT06727136 is a clinical study titled "A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants". 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 ...
What is the current status of trial NCT06727136?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2024-11-20. Estimated completion is 2025-04-22.
What conditions does trial NCT06727136 study?
This clinical trial studies the following conditions: Healthy Participants.
What interventions are being tested in trial NCT06727136?
The interventions under investigation include: TBP-PI-HBr (DRUG).
Who is sponsoring clinical trial NCT06727136?
This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06727136 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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