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Unknown

Period 5 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72, and 96 hours post dose in periods 2, 5, and 8

Awards & highlights

Study Summary

This trial studies how PF-07081532 affects the movement of two medicines, dabigatran and rosuvastatin, in the body of healthy overweight or obese adults.

Eligible Conditions

Healthy Subjects

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72, and 96 hours post dose in periods 2, 5, and 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72, and 96 hours post dose in periods 2, 5, and 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72, and 96 hours post dose in periods 2, 5, and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of rosuvastatin [if data permits otherwise Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)]

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of total dabigatran [if data permits otherwise Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)]

Secondary outcome measures

Apparent Oral Clearance (CL/F) of rosuvastatin

Apparent Oral Clearance (CL/F) of total dabigatran

Apparent Volume of Distribution (Vz/F) of rosuvastatin

+14 more

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Period 8Experimental Treatment2 Interventions

Participants will receive PF-07081532 daily and rosuvastatin as a single dose

Group II: Period 7Experimental Treatment2 Interventions

Participants will receive PF-07081532 daily and DE as a single dose

Group III: Period 5Experimental Treatment2 Interventions

Participants will receive PF-07081532 daily and rosuvastatin as a single dose

Group IV: Period 4Experimental Treatment2 Interventions

Participants will receive PF-07081532 daily and DE as a single dose

Group V: Period 2Active Control1 Intervention

Participants will receive rosuvastatin as a single dose

Group VI: Period 3Active Control1 Intervention

Participants will receive PF-07081532 daily titrated

Group VII: Period 6Active Control1 Intervention

Participants will receive PF-07081532 daily titrated

Group VIII: Period 1Active Control1 Intervention

Participants will receive dabagatrin etexilate (DE) as a single dose

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-07081532

2022

Completed Phase 1

~170

Rosuvastatin

2019

Completed Phase 4

~3150

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,857 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,093,025 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks do people face when experiencing Period 8?

"The limited clinical data available on Period 8 led our team at Power to assign it a safety score of 1. This is due to the Phase 1 status, signifying that its safety and efficacy have been minimally tested."

Answered by AI

How many participants is the cap for this research endeavor?

"Affirmative. According to the records on clinicaltrials.gov, this investigation is currently recruiting participants. It was first publicized on March 27th 2023 and a recent update occurred on April 17th of that same year; 24 individuals are required from one medical facility."

Answered by AI

Is enrollment for this research endeavor still open?

"That is accurate. The details listed on clinicaltrials.gov state that patient recruitment for this trial started on March 27th 2023 and the most recent update was provided on April 17th 2023. This investigation requires 24 participants from a single research site to fulfill their enrollment needs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05788328.