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NCT05527834 · ClinicalTrials.gov registry record · Phase 1
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
A Phase 1 study of Pharmacokinetics, sponsored by Basilea Pharmaceutica.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05527834: Completed Phase 1 study of Pharmacokinetics, sponsored by Basilea Pharmaceutica.
NCT05527834 is a Phase 1 study of Pharmacokinetics that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 24 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05527834, a Phase 1 study of Pharmacokinetics, has completed, sponsored by Basilea Pharmaceutica.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
Primary Outcome
Maximum observed plasma concentration (Cmax)
Conditions Studied
Interventions
- DRUG Ceftibuten
- DRUG VNRX-7145
Study Locations (1)
Kansas
- ICON Plc. - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2023-02-10 |
| Phase | Phase 1 |
What the finished NCT05527834 record still lists
NCT05527834 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 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 2 interventions - of which Ceftibuten is the first listed.
NCT05527834 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT05527834 about?
NCT05527834 is a clinical study titled "Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants". This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a...
What is the current status of trial NCT05527834?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-09-13. Estimated completion is 2023-02-10.
What conditions does trial NCT05527834 study?
This clinical trial studies the following conditions: Pharmacokinetics.
What interventions are being tested in trial NCT05527834?
The interventions under investigation include: Ceftibuten (DRUG), VNRX-7145 (DRUG).
Who is sponsoring clinical trial NCT05527834?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05527834 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05527834's enrollment target sits among peer trials
24 23rd of 37 higher than 12 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pharmacokinetics 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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