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Period 2: Cyclosporine + PF-07081532 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) 0.5 1 2 4 6 8 10 12 14 24 36 48 72 96 and 120 hours post dose

Awards & highlights

Study Summary

This trial will look at how multiple doses of medicine affect the single-dose PK of an experimental medicine in overweight/obese adults.

Eligible Conditions

Healthy Subjects

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (pre-dose) 0.5 1 2 4 6 8 10 12 14 24 36 48 72 96 and 120 hours post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (pre-dose) 0.5 1 2 4 6 8 10 12 14 24 36 48 72 96 and 120 hours post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose) 0.5 1 2 4 6 8 10 12 14 24 36 48 72 96 and 120 hours post dose for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

AUCinf (if data permita otherwise AUClast): To estimate the effect of single dose of cyclosporine on the single dose of PF-07081532 in otherwise healthy, overweight or obese participants.

AUCinf (if data permits otherwise AUClast): To estimate the effect of muliple dose itraconazole on thes single dose of PF-07081532 in otherwise healthy, overweight or obese participants.

Secondary outcome measures

Apparent Oral Clearance (CL/F) of PF-07081532

Apparent Volume of Distribution (Vz/F) of PF-07081532

Maximum Observed Plasma Concentration (Cmax) of PF-07081532

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Period 3: Itraconazole + PF-07081532Experimental Treatment2 Interventions

Participants will receive itraconazole daily for 9 days plus a single dose of PF-07081532 on Day 4.

Group II: Period 2: Cyclosporine + PF-07081532Experimental Treatment2 Interventions

Participants will receive a single dose of PF-07081532 and a single dose of cyclosporine on Day 1.

Group III: Period 1: PF-07081532Active Control1 Intervention

Participants will receive PF-07081532 as a single dose on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclosporine

1997

Completed Phase 3

~1830

PF-07081532

2022

Completed Phase 1

~170

Itraconazole

2017

Completed Phase 2

~780

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,910,424 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,475 Previous Clinical Trials

8,091,538 Total Patients Enrolled

Frequently Asked Questions

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

Has the combination of Cyclosporine and PF-07081532 been authorized by the FDA?

"The safety of Cyclosporine + PF-07081532 was evaluated to be a 1 since this is Phase 1 trial, indicating that there are only preliminary data confirming both its efficacy and safety."

Answered by AI

How many participants are being recruited for this experiment?

"Confirmed. The information available on clinicaltrials.gov confirms that this trial is presently enrolling participants, having been initially posted on February 22nd 2023 and most recently updated two weeks later. Subsequently, the team needs to recruit 16 patients from 1 site."

Answered by AI

Is recruitment for this investigation still open?

"According to the clinicaltrials.gov database, this medical trial is currently enrolling patients. This protocol was initiated on February 22nd 2023 and has been updated as recently as March 2nd 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults

2023. "A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05745701.