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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 is a Phase 1 study that has completed, run by Spero Therapeutics. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04238195
The ClinicalTrials.gov registry entry for NCT04238195 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 4 interventions - of which Moxifloxacin 400mg is the first listed.
NCT04238195 reports 0 study locations.
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.
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