A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers
Study Details
Study Description
Brief Summary
The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Period 1 formulation 1 PF-07817883 Single oral dose of PF-07817883 tablet under fasted condition |
Drug: Drug: PF-07817883
PF-07817883 tablet
|
| Experimental: Period 2 formulation 2 PF-07817883 Single oral dose of PF-07817883 tablet under fasted condition |
Drug: Drug: PF-07817883
PF-07817883 tablet
|
| Experimental: Period 3 formulation 3 PF-07817883 Single oral dose of PF-07817883 tablet under fasted condition |
Drug: Drug: PF-07817883
PF-07817883 tablet
|
| Experimental: Period 4 formulation 4 PF-07817883 Single oral dose of PF-07817883 tablet under fasted condition |
Drug: Drug: PF-07817883
PF-07817883 tablet
|
Outcome Measures
Primary Outcome Measures
- Cmax in each of the periods to compare test with reference [Through 48 hours in period 1, 2, 3 and 4]
The Cmax (maximum observed plasma concentration) is estimated based on the plasma concentrations for test and reference formulation
- AUC in each of the periods to compare test with reference [Through 48 hours in period 1, 2, 3 and 4]
The AUC (area under plasma concentration curve) for test and reference formulation
Secondary Outcome Measures
- Number of participants with Treatment Emergent Adverse Events (TEAE) [Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention]
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment
- Number of Participants With Laboratory Abnormalities [Through completion of in-clinic study (10 days)]
Laboratory examination includes hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose);urinalysis (decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin]).
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Through completion of in-clinic study (10 days)]
Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.
- Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings [Through completion of in-clinic study (10 days)]
Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
-
BMI of 16 to 32 kg/m2; and a total body weight >45 kg
-
Capable of giving signed informed consent.
Exclusion Criteria:
-
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
-
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).
-
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
-
History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
- Positive test result for SARS-CoV-2 infection at admission
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C5091013