A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.
NCT ID: NCT05767905
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2023-03-17
2023-06-20
Brief Summary
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The study is seeking for male and female participants who:
* Are 18 years of age or more.
* Are confirmed to be healthy after performing some medical and physical tests.
* Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more.
The study consists of two parts. In each part of the study, the selected participants will take part in 3 study periods to receive 3 different treatments which are randomly assigned. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of next study period.
Each treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions.
How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after each administration. The results will be used to see the effect of tablet formulation and presence of food on the amount of PF-06821497 available in the blood of the participants.
In each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Part 1: PF-06821497 Sequence 1
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
PF-06821497 Treatment A
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment B
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment C
A single dose of PF-06821497 administered under fasting conditions.
Part 1: PF-06821497 Sequence 2
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
PF-06821497 Treatment A
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment B
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment C
A single dose of PF-06821497 administered under fasting conditions.
Part 2: PF-06821497 Sequence 1
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
PF-06821497 Treatment D
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment E
A single dose of PF-06821497 administered after low fat meal
PF-06821497 Treatment F
A single dose of PF-06821497 administered after high fat meal.
Interventions
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PF-06821497 Treatment A
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment B
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment C
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment D
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment E
A single dose of PF-06821497 administered after low fat meal
PF-06821497 Treatment F
A single dose of PF-06821497 administered after high fat meal.
Eligibility Criteria
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Inclusion Criteria
* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
* BMI of ≥17.5 kg/m2; and a total body weight \>50 kg (110 lb)
* Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion Criteria
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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New Haven Clinical Research Unit
New Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05767905
Identifier Type: REGISTRY
Identifier Source: secondary_id
C2321005
Identifier Type: -
Identifier Source: org_study_id
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