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NCT03937258 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Pharmacokinetics of PF-04965842 and Its Metabolites and Effect of Probenecid in Healthy Participants
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03937258 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 12 participants.
The verdict
NCT03937258, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
A total of approximately 12 healthy male or female participants will be enrolled in the study so that at least 10 participants will complete the study. Participants will be screened within 28 days of the first dose of study medication. The single fixed-sequence will consist of 3 periods. Participants will report to the clinical research unit (CRU) at least 12 hours prior to Day 1 dosing in Period 1 and will be required to stay in the CRU for 12 days and 11 nights. Genotyping samples for cytochrome P450 (CYP) 2C19 and CYP2C9 will be collected pre dose in Period 1 only. In Period 1, participants will be administered a single oral 200 mg dose of PF-04965842 in the morning on Day 1 under fasted conditions (overnight fasting for at least 10 hours). No food will be allowed for at least 4 hours postdose and undergo serial blood sample collection for 48 hours postdose. In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the morning of Day 1 to Day 4 under fasted conditions (overnight fasting for at least 10 hours). No food will be allowed for at least 4 hours postdose and undergo serial blood sample collection for 48 hours postdose on Day 4. In Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose. Participants will remain in a fasted state for 4 hours after dosing with PF 04965842 and undergo serial blood sample collection for 48 hours post PF 04965842 dosing. Participants will be discharged from the CRU on Day 4 after all study procedures are completed. The participant will be required to have a Follow-up phone contact 28-35 days after the last dose of investigational product.
Interventions
- DRUG Probenecid
- DRUG PF-04965842
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-05-21 |
| Est. Completion | 2019-07-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03937258
The ClinicalTrials.gov registry entry for NCT03937258 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 2 interventions - of which Probenecid is the first listed.
NCT03937258 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03937258 about?
NCT03937258 is a clinical study titled "A Study to Assess Pharmacokinetics of PF-04965842 and Its Metabolites and Effect of Probenecid in Healthy Participants". A total of approximately 12 healthy male or female participants will be enrolled in the study so that at least 10 participants will complete the study. Participants will be screened within 28 days of the first dose of study medication. The single fixed-sequence will consist of 3 periods. Participan...
What is the current status of trial NCT03937258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-05-21. Estimated completion is 2019-07-26.
What interventions are being tested in trial NCT03937258?
The interventions under investigation include: Probenecid (DRUG), PF-04965842 (DRUG).
Who is sponsoring clinical trial NCT03937258?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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