A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants

Healthy Clinical Trial

Official title:

A PHASE 1, RANDOMIZED, OPEN-LABEL, 4-PERIOD, 5-TREATMENT, 6-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE BIOAVAILABILITY OF PF-07104091

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05431153
• Other study ID #: C4161007
• Status: Completed
• Phase: Phase 1
• Start date: June 10, 2022
• Est. completion date: October 17, 2022

Study information

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

Clinical Trial Summary

This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 17, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs.
• Body-Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of >50 kg (110 lb).
• Written evidence of a personally signed and dated informed consent document (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).
• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAB) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
• 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 (eg, contact with positive case, residence, or travel to an area with high incidence) 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.
• A positive urine drug test.
• History of sensitivity to heparin or heparin induced thrombocytopenia.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
• Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
• Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
• Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
• Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.

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 Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C	AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.	Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Primary	Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C	Cmax was maximum observed concentration. Cmax was observed directly from data.	Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	AUCinf of PF-07104091 for Treatment C, D and E	AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.	Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Cmax of PF-07104091 for Treatment C, D and E	Cmax was maximum observed concentration. Cmax was observed directly from data.	Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	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 adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, other important medical events. TEAEs were defined as events that occurred after start of treatment.	From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Secondary	Number of Participants With Laboratory Test Abnormalities	Clinical hematology parameters included: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry parameters included: blood urea nitrogen and creatinine, cystatin C and estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, urinalysis parameters included: local dipstick: potential of hydrogen (pH), glucose, protein, blood, ketones, nitrites, leukocyte esterase. Number of participants with abnormal findings are presented in this outcome measure.	From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Secondary	Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments	A 12-lead ECG was performed. Clinically meaningful findings in ECG assessments were based on the investigator's judgment.	From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Secondary	Number of Participants With Clinically Meaningful Findings in Vital Signs	Vital signs were measured with the participant's arm supported at the level of the heart after approximately 5 minutes of rest. Vital signs parameters included: diastolic and systolic blood pressure, respiratory rate, pulse rate, and temperature. Number of participants with clinically meaningful findings in any vital sign parameter were reported. Clinically meaningful findings were based on the investigator's judgment.	From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Secondary	Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments	A complete physical examination included at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Clinically significant findings were defined according to investigator's assessment.	From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)

External Links

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