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NCT05788328 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT05788328 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 16 participants.
The verdict
NCT05788328, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of the study was to understand the effect of PF-07081532 on the movement of Dabigatran and Rosuvastatin into, though, and out of the body in healthy overweight or obese adult participants. This study also aims to collect data on safety and how tolerable the study medicine is. The study is seeking for participants who are: * Male or female who are 18 years of age or older. * Healthy but are overweight or obese. Participants will receive dabigatran and rosuvastatin as single doses by mouth 3 times during the study. The amount of the study medicine PF-07081532 will be adjusted over time until any interactions are seen. PF-07081532 is taken daily by mouth in 8 Study Periods while admitted into the study clinic over 53 days. Once discharged from the study clinic, participants will have a follow-up visit 7 to 10 days post last dose of study medicine. Then another follow-up via telephone contact, 28 to 35 days post last dose of study medicine.
Interventions
- DRUG Rosuvastatin
- DRUG PF-07081532
- DRUG Dabigatran etexilate (DE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-03-27 |
| Est. Completion | 2023-09-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05788328
The ClinicalTrials.gov registry entry for NCT05788328 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rosuvastatin is the first listed.
NCT05788328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05788328 about?
NCT05788328 is a clinical study titled "A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants". The purpose of the study was to understand the effect of PF-07081532 on the movement of Dabigatran and Rosuvastatin into, though, and out of the body in healthy overweight or obese adult participants. This study also aims to collect data on safety and how tolerable the study medicine is. The study ...
What is the current status of trial NCT05788328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-03-27. Estimated completion is 2023-09-11.
What interventions are being tested in trial NCT05788328?
The interventions under investigation include: Rosuvastatin (DRUG), PF-07081532 (DRUG), Dabigatran etexilate (DE) (DRUG).
Who is sponsoring clinical trial NCT05788328?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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