A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers

Healthy Clinical Trial

Official title:

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07817883 FOLLOWING ORAL ADMINISTRATION OF NEW FORMULATIONS RELATIVE TO THE REFERENCE FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06122194
• Other study ID #: C5091013
• Status: Completed
• Phase: Phase 1
• Start date: November 23, 2023
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

1. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

2. 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Drug: PF-07817883
PF-07817883 tablet

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit - Brussels	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax in each of the periods to compare test with reference	The Cmax (maximum observed plasma concentration) is estimated based on the plasma concentrations for test and reference formulation	Through 48 hours in period 1, 2, 3 and 4
Primary	AUC in each of the periods to compare test with reference	The AUC (area under plasma concentration curve) for test and reference formulation	Through 48 hours in period 1, 2, 3 and 4
Secondary	Number of participants with Treatment Emergent Adverse Events (TEAE)	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	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
Secondary	Number of Participants With Laboratory Abnormalities	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]).	Through completion of in-clinic study (10 days)
Secondary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), respiratory rate and pulse rate.	Through completion of in-clinic study (10 days)
Secondary	Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings	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	Through completion of in-clinic study (10 days)

External Links

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