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NCT05745701 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT05745701: Completed Phase 1 study, sponsored by Pfizer.
NCT05745701 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05745701, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, fixed-sequence, 3-period study to evaluate the effect of multiple doses of itraconazole and a single dose of cyclosporine on the single-dose PK of PF-07081532 in otherwise healthy, overweight or obese, adult female and male participants. The 3 study periods will be conducted consecutively without a break.
Primary Outcome
AUCinf is area under the plasma concentration-time profile from time zero extrapolated to infinite time. AUCinf is caluculated by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Interventions
- DRUG Itraconazole
- DRUG PF-07081532
- DEVICE Cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-02-22 |
| Est. Completion | 2023-05-29 |
| Phase | Phase 1 |
What the finished NCT05745701 record still lists
NCT05745701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.
NCT05745701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05745701 about?
NCT05745701 is a clinical study titled "A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults". This is a Phase 1, open-label, fixed-sequence, 3-period study to evaluate the effect of multiple doses of itraconazole and a single dose of cyclosporine on the single-dose PK of PF-07081532 in otherwise healthy, overweight or obese, adult female and male participants. The 3 study periods will be co...
What is the current status of trial NCT05745701?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-02-22. Estimated completion is 2023-05-29.
What interventions are being tested in trial NCT05745701?
The interventions under investigation include: Itraconazole (DRUG), PF-07081532 (DRUG), Cyclosporine (DEVICE).
Who is sponsoring clinical trial NCT05745701?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05745701's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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