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

Healthy Clinical Trial

Official title:

A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, CROSSOVER, SINGLE-DOSE, 2-PART STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE RELATIVE BIOAVAILABILITY OF PF-06821497

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05767905
• Other study ID #: C2321005
• Status: Completed
• Phase: Phase 1
• Start date: March 17, 2023
• Est. completion date: June 20, 2023

Study information

• Verified date: July 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants =18 years of age, inclusive, at screening.

• 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:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or prior allergic reaction to any component of PF-06821497.

• 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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Primary	Maximum Observed Plasma Concentration (Cmax) of PF-06821497 to estimate relative bioavailability for Treatments A and B		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	AUCinf of PF-06821497 for Treatment C relative to Treatments B and A		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Cmax of PF-06821497 for Treatment C relative to Treatments B and A		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	AUCinf of PF-06821497, comparison of low fat meal with fasted		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	AUCinf of PF-06821497, comparison of high fat meal with fasted		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	AUCinf of PF-06821497 Treatment D - Fasted		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	AUCinf of PF-06821497 Treatment E - low fat meal		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	AUCinf of PF-06821497 Treatment F - high fat meal		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Cmax of PF-06821497, comparison of low fat meal with fasted		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Cmax of PF-06821497, comparison of high fat meal with fasted		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Cmax of PF-06821497 Treatment D - Fasted		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Cmax of PF-06821497 Treatment E - low fat meal		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Cmax of PF-06821497 Treatment F - high fat meal		0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Participants With Laboratory Abnormalities		From baseline up to 35 days after final dose of PF-06821497
Secondary	Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings		From baseline up to 35 days after final dose of PF-06821497
Secondary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs		From baseline up to 35 days after final dose of PF-06821497
Secondary	Number of Participants With Abnormalities in Physical Examination		From baseline up to 35 days after final dose of PF-06821497

External Links

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