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NCT04368585 · ClinicalTrials.gov registry record · Phase 1
Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
A Phase 1 study, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04368585: Completed Phase 1 study, sponsored by Spero Therapeutics.
NCT04368585 is a Phase 1 study that has completed, run by Spero Therapeutics. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04368585, a Phase 1 study, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.
Interventions
- DRUG Omeprazole
- DRUG Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
- DRUG 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2020-08-21 |
| Phase | Phase 1 |
What the finished NCT04368585 record still lists
NCT04368585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Omeprazole is the first listed.
NCT04368585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04368585 about?
NCT04368585 is a clinical study titled "Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects". To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.
What is the current status of trial NCT04368585?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-07-01. Estimated completion is 2020-08-21.
What interventions are being tested in trial NCT04368585?
The interventions under investigation include: Omeprazole (DRUG), Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) (DRUG), 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) (DRUG).
Who is sponsoring clinical trial NCT04368585?
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 NCT04368585's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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