A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.

Healthy Clinical Trial

Official title:

A Phase 1, Open-Label, 2-Period, Fixed Sequence Study to Estimate the Effect of Itraconazole on the Pharmacokinetics of PF-07817883 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822440
• Other study ID #: C5091008
• Status: Completed
• Phase: Phase 1
• Start date: April 13, 2023
• Est. completion date: July 10, 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 learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults.

This study is seeking participants who are:

• male and female aged 18 to 65 years old,

• overtly healthy. This can be determined my medical evaluation, medical history, lab tests etc.

This study will consist of 2 parts, Period 1 and Period 2.

Period 1: participants will take PF-07817883 one time by mouth at the study clinic.

Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days.

Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants' reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883.

Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors.

Description:

This is a Phase 1, open-label, 2-period, fixed sequence study to estimate the effect of itraconazole, a strong CYP3A4 inhibitor, on the plasma PK of PF-07817883 in healthy adults. The study will consist of 2 treatments: a single oral dose of PF-07817883 alone and a single oral dose of PF-07817883 in combination with multiple oral doses of itraconazole. The PK and safety will be assessed and compared for single dose of PF-07817883 in period 1 and period 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female participants aged 18 to 65 years of age, inclusive, 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 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lb).

• Capable of giving signed informed consent.

Exclusion Criteria:

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions 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, CV, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

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

• Positive test result for SARS-CoV-2 infection at admission.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07817883
Single oral dose (period 1) or co-administered with itraconazole (period 2)
• Itraconazole
Interacting drug which will be given for 7 days in period 2

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	Cmax ratio of PF-07817883 alone vs coadministration with itraconazole	The ratio of maximum plasma concentration of PF-07817883 following single dose co-administered with itraconazole vs given alone	0 to 96 hours post PF-07817883
Primary	AUC ratio of PF-07817883 alone vs coadministration with itraconazole	The ratio of AUC (area under plasma concentration curve) of PF-07817883 following single dose co-administered with itraconazole vs given alone	0 to 96 hours post PF-07817883
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]).	Baseline (Study Day -28 to -1) up to Period 2 Day 8 (Study Day 13)
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	Baseline (Study Day -28 to -1) up to Period 2 Day 8 (Study Day 13)
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.	Baseline (Study Day -28 to -1) up to Period 2 Day 8 (Study Day 13)
Secondary	Number of Participants With Clinically Significant findings in physical exam	A complete physical examination will include, 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 will include, at a minimum, assessments of general appearance, the respiratory and CV systems, and participant-reported symptoms.	Baseline (Study Day -28 to -1)
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07817883, when administered alone	Observed directly from data	Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07817883, when administered with itraconazole	Observed directly from data	Period 2 Day 4 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours after PF-07817883 dose
Secondary	Plasma Decay Half-Life (t1/2) of PF-07817883, when administered alone	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Secondary	Plasma Decay Half-Life (t1/2) of PF-07817883, when administered with itraconazole	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Period 2 Day 4 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours after PF-07817883 dose
Secondary	Apparent Oral Clearance (CL/F) of PF-07817883, when administered alone	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.	Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Secondary	Apparent Oral Clearance (CL/F) of PF-07817883, when administered with itraconazole	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.	Period 2 Day 4 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours after PF-07817883 dose
Secondary	Apparent Volume of Distribution (Vz/F) of PF-07817883, when administered alone	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Secondary	Apparent Volume of Distribution (Vz/F) of PF-07817883, when administered with itraconazole	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	Period 2 Day 4 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours after PF-07817883 dose

External Links

•   To obtain contact information for a study center near you, click here.