Part 1: PF-06821497 Sequence 2 for Healthy Subjects

New Haven Clinical Research Unit, New Haven, CT
Healthy SubjectsPF-06821497 Treatment F - Drug
Eligibility
18 - 55
All Sexes
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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.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Treatment sequence B-A
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Treatment D
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Sequence A

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Hour 48
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
AUCinf of PF-06821497 for Treatment C relative to Treatments B and A
AUCinf of PF-06821497, comparison of high fat meal with fasted
AUCinf of PF-06821497, comparison of low fat meal with fasted
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
Cmax of PF-06821497 Treatment D - Fasted
Cmax of PF-06821497 Treatment E - low fat meal
Cmax of PF-06821497 Treatment F - high fat meal
Cmax of PF-06821497 for Treatment C relative to Treatments B and A
Cmax of PF-06821497, comparison of high fat meal with fasted
Cmax of PF-06821497, comparison of low fat meal with fasted
Maximum Observed Plasma Concentration (Cmax) of PF-06821497 to estimate relative bioavailability for Treatments A and B
Day 35
Number of Participants With Abnormalities in Physical Examination
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Participants With Laboratory Abnormalities

Trial Safety

Phase-Based Safety

1 of 3

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1
Treatment sequence B-A
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Treatment D
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Sequence A

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Part 1: PF-06821497 Sequence 2
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Part 1: PF-06821497 Sequence 1
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Part 2: PF-06821497 Sequence 1
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Experimental Treatment

18 Total Participants · 3 Treatment Groups

Primary Treatment: Part 1: PF-06821497 Sequence 2 · No Placebo Group · Phase 1

Part 1: PF-06821497 Sequence 2Experimental Group · 3 Interventions: PF-06821497 Treatment A, PF-06821497 Treatment B, PF-06821497 Treatment C · Intervention Types: Drug, Drug, Drug
Part 1: PF-06821497 Sequence 1Experimental Group · 3 Interventions: PF-06821497 Treatment A, PF-06821497 Treatment B, PF-06821497 Treatment C · Intervention Types: Drug, Drug, Drug
Part 2: PF-06821497 Sequence 1Experimental Group · 3 Interventions: PF-06821497 Treatment F, PF-06821497 Treatment E, PF-06821497 Treatment D · Intervention Types: Drug, Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Who is running the clinical trial?

PfizerLead Sponsor
4,397 Previous Clinical Trials
25,775,143 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,341 Previous Clinical Trials
23,427,746 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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