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Part 1: PF-06821497 Sequence 1 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, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Awards & highlights

Study Summary

This trial will study how the medicine PF-06821497 is processed by the body when taken in two different forms and with/without food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 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

Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of PF-06821497 to estimate relative bioavailability for Treatments A and B

Maximum Observed Plasma Concentration (Cmax) of PF-06821497 to estimate relative bioavailability for Treatments A and B

Secondary outcome measures

AUCinf of PF-06821497 Treatment D - Fasted

AUCinf of PF-06821497 Treatment E - low fat meal

AUCinf of PF-06821497 Treatment F - high fat meal

+13 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2: PF-06821497 Sequence 1Experimental Treatment3 Interventions

Participants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: Drug: Single dose of PF-06821497 Treatment D Drug: Single dose of PF-06821497 Treatment E Drug: Single dose of PF-06821497 Treatment F

Group II: Part 1: PF-06821497 Sequence 2Experimental Treatment3 Interventions

Participants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: Drug: Single dose of PF-06821497 Treatment A Drug: Single dose of PF-06821497 Treatment B Drug: Single dose of PF-06821497 Treatment C

Group III: Part 1: PF-06821497 Sequence 1Experimental Treatment3 Interventions

Participants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: Drug: Single dose of PF-06821497 Treatment A Drug: Single dose of PF-06821497 Treatment B Drug: Single dose of PF-06821497 Treatment C

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-06821497 Treatment A

2023

Completed Phase 1

~20

PF-06821497 Treatment B

2023

Completed Phase 1

~20

PF-06821497 Treatment C

2023

Completed Phase 1

~20

PF-06821497 Treatment D

2023

Completed Phase 1

~20

PF-06821497 Treatment E

2023

Completed Phase 1

~20

PF-06821497 Treatment F

2023

Completed Phase 1

~20

Do I qualify?Apply below to find out

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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

10,911,856 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,093,024 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 deleterious effects has Part 1: PF-06821497 Sequence 2 been found to have on humans?

"Our power team has assigned the safety of Part 1: PF-06821497 Sequence 2 a score of 1, as this is an initial Phase 1 trial with limited data on its efficacy and security."

Answered by AI

Is there ongoing recruitment for this experiment?

"According to the clinicaltrials.gov listing, this study is not actively seeking enrolment at present. The trial was initially advertised on March 18th 2023 and its last edit occurred a day before that; however, 823 other trials are currently open for participation."

Answered by AI

Who is eligible to be enrolled in this research study?

"This clinical trial has a set of eligibility criteria that requires participants to be in good health and within the age range of 18-55. Currently, approximately eighteen individuals are being accepted into this research endeavour."

Answered by AI

Are applicants above thirty years of age eligible for this research experiment?

"This study can accept patients aged 18 to 55 as indicated by the eligibility criteria. Other trials are available for those younger than 18 and older than 65, with 54 studies open to minors and 368 catered towards seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.

2023. "A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05767905.