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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 is a Phase 1 study that has completed, run by Spero Therapeutics. The registered enrollment target is 20 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04368585
The ClinicalTrials.gov registry entry for NCT04368585 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 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 3 interventions - of which Omeprazole is the first listed.
NCT04368585 reports 0 study locations.
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.
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