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NCT04238195 · ClinicalTrials.gov registry record · Phase 1
A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects
A Phase 1 study, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04238195: Completed Phase 1 study, sponsored by Spero Therapeutics.
NCT04238195 is a Phase 1 study that has completed, run by Spero Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04238195, a Phase 1 study, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide \[TBPM-PI-HBr\]/placebo only), placebo- and active-control, single-dose, 4-way crossover study that will enroll 24 healthy adult male and female subjects. There will be a washout period of at least 7 days between dosing in each period and each subject will receive all 4 treatments over 4 periods in a crossover study design.
Primary Outcome
Holter monitors will be used to collect continuous 12-lead electrocardiogram (ECG) data on Day 1. Triplicate 10-second, 12-lead ECG recordings will be extracted from the Holter monitor data within a 5-minute time window prior to the pharmacokinetic (PK) blood samples collected as close to the exact time point as possible
Interventions
- DRUG Moxifloxacin 400mg
- DRUG Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo
- OTHER Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)
- DRUG Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-01-19 |
| Est. Completion | 2020-02-26 |
| Phase | Phase 1 |
What the finished NCT04238195 record still lists
NCT04238195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin 400mg is the first listed.
NCT04238195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04238195 about?
NCT04238195 is a clinical study titled "A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects". This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide \[TBPM-PI-HBr\]/placebo only), placebo- and active-control, single-dose, 4-way crossover study that will enroll 24 healthy adult male and female subjects. There will be a washout period of at least 7 days between dosi...
What is the current status of trial NCT04238195?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-01-19. Estimated completion is 2020-02-26.
What interventions are being tested in trial NCT04238195?
The interventions under investigation include: Moxifloxacin 400mg (DRUG), Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo (DRUG), Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) (OTHER), Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) (DRUG).
Who is sponsoring clinical trial NCT04238195?
This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04238195's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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