A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05767905
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1: PF-06821497 Sequence 2 PF-06821497 Treatment C 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 Part 1: PF-06821497 Sequence 1 PF-06821497 Treatment C 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 Part 1: PF-06821497 Sequence 1 PF-06821497 Treatment A 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 Part 1: PF-06821497 Sequence 1 PF-06821497 Treatment B 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 Part 1: PF-06821497 Sequence 2 PF-06821497 Treatment A 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 Part 2: PF-06821497 Sequence 1 PF-06821497 Treatment D 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 Part 2: PF-06821497 Sequence 1 PF-06821497 Treatment E 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 Part 2: PF-06821497 Sequence 1 PF-06821497 Treatment F 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 Part 1: PF-06821497 Sequence 2 PF-06821497 Treatment B 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
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497 Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3. The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration
Maximum Plasma Concentration (Cmax) for PF-06821497. Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3. The Cmax was observed directly from data.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs). From screening up to Day 35 An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious.
Number of Participants With Laboratory Abnormalities From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks. Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.
Number of Participants With Clinically Significant ECG Findings From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks. Single 12-lead electrocardiogram or electrocardiography (ECG) readings were taken at approximately each test. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.
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Trial Locations
- Locations (1)
New Haven Clinical Research Unit
🇺🇸New Haven, Connecticut, United States
New Haven Clinical Research Unit🇺🇸New Haven, Connecticut, United States