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NCT06733675 · ClinicalTrials.gov registry record · Phase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
A Phase 1 study of Healthy Volunteer and Pharmacokinetics, sponsored by Basilea Pharmaceutica.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT06733675: Recruiting Phase 1 study of Healthy Volunteer and Pharmacokinetics, sponsored by Basilea Pharmaceutica.
NCT06733675 is a Phase 1 study of Healthy Volunteer and Pharmacokinetics that is actively recruiting participants, run by Basilea Pharmaceutica. The registered enrollment target is 46 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06733675, a Phase 1 study of Healthy Volunteer and Pharmacokinetics, is actively recruiting participants, sponsored by Basilea Pharmaceutica.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.
Primary Outcome
Area under the concentration time curve from time zero to infinity (AUC0-∞)
Conditions Studied
Interventions
- DRUG Esomeprazole
- DRUG Ledaborbactam etzadroxil
- DRUG Ceftibuten
- DRUG Ceftibuten-ledaborbactam etzadroxil
Study Locations (1)
Kansas
- ICON, Clinical Research Phase I Unit - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2025-01-07 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT06733675 shows while recruiting
NCT06733675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (77% lower).
The record links to 5 conditions, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions - of which Esomeprazole is the first listed.
NCT06733675 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT06733675 about?
NCT06733675 is a clinical study titled "Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination". This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants ...
What is the current status of trial NCT06733675?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2025-01-07. Estimated completion is 2026-06-30.
What conditions does trial NCT06733675 study?
This clinical trial studies the following conditions: Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI), FDC.
What interventions are being tested in trial NCT06733675?
The interventions under investigation include: Esomeprazole (DRUG), Ledaborbactam etzadroxil (DRUG), Ceftibuten (DRUG), Ceftibuten-ledaborbactam etzadroxil (DRUG).
Who is sponsoring clinical trial NCT06733675?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06733675 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06733675's enrollment target sits among peer trials
46 62nd of 112 higher than 50 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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.
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