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HealthyPhase 1NCT05822440

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

A Phase 1 study testing PF-07817883 and Itraconazole in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-07817883 and Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
13 Apr 2023to 10 Jul 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

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

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:

Read more
  • 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.

Read the detailed 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.

Conditions
Healthy
Being tested
PF-07817883, Itraconazole
Keywords
COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07817883Drug

    Single oral dose (period 1) or co-administered with itraconazole (period 2)

  • ItraconazoleDrug

    Also called Sporanox®

    Interacting drug which will be given for 7 days in period 2

Study groups in NCT05822440
Study groupRoleWhat they receive
Period 1ExperimentalThe treatment arm includes a single dose of PF-07817883 (Period 1 Day 1)
Receives: Drug: PF-07817883
Period 2ExperimentalThis treatment arm includes 7-day dosing of itraconazole with a single dose of PF-07817883 Co-administered on Day 4 (Period 2 Day 4)
Receives: Drug: PF-07817883; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Concentration (Cmax) of PF-07817883

    Cmax was observed directly from data and measured in nanogram per milliliter (ng/mL).

    Measured: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

  2. Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883

    AUCinf was derived by AUClast + (Clast*/kel). AUClast was area under the plasma concentration-time profile from time 0 to the time of Clast; 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 loglinear concentration-time curve. AUCinf was measured in nanogram*hour per milliliter (ng*hr/mL).

    Measured: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

Secondary outcomes (9)
  1. Number of Participants With Treatment Emergent Adverse Events (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 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 defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs were events that occurred between first dose of study intervention and up to maximum of 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

    Measured: Day 1 of dosing up to 35 days post last dose of study intervention (maximum up to 48 days)

  2. Number of Participants With Laboratory Test Abnormalities

    Laboratory assessments included: hematology assessments included monocytes/leukocytes (percentage [%]) greater than (>) 1.2*upper limit of normal (ULN), urinalysis assessments included urine hemoglobin greater than or equal to (>=) 1, low power field (LPF), urine bacteria >20/LPF.

    Measured: Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days)

  3. Number of Participants With Electrocardiogram (ECG) Findings Per Pre-defined Criteria

    Standard 12-lead ECGs was collected using an ECG system that automatically calculates the heart rate (HR) and measures PR interval, QT interval, QTcF, and QRS interval. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. To ensure safety of the participants, a qualified individual at the investigator site made comparisons to baseline measurements. Pre-defined criteria was defined as 30 milliseconds (ms) less than (<) change less than or equal to (<=) 60 ms.

    Measured: Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days)

  4. Number of Participants With Vital Signs Findings Per Pre-defined Criteria

    Vital signs included: supine diastolic blood pressure (DBP) measured in millimetre of mercury (mmHg) with criteria value as follows- Value <50 mmHg, change>= 20 mmHg increase, change >= 20 mmHg decrease; supine pulse rate (PR) measured in beats per minute (bpm) with criteria values as follows- value < 40 bpm, value > 120 bpm; supine systolic blood pressure (SBP, mmHg) with criteria values as follows- value< 90 mmHg, change >= 30 mmHg increase, change >=30 mmHg decrease. Vital signs (SBP BP, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Supine BP was measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest. If timing of these measurements coincided with a blood collection, BP and PR were obtained prior to nominal time of blood collection. Only participants having at least 1 vital sign findings per pre-defined criteria are reported.

    Measured: Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days)

  5. Number of Participants With Clinically Significant Abnormalities in Physical Examination

    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 CV systems, and participant-reported symptoms. Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. Clinical significance of physical examination abnormalities was judged by physicians.

    Measured: Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days)

  6. Time to Reach Cmax (Tmax) of PF-07817883

    Tmax is the time taken (in hours) to reach the maximum serum drug concentration. Tmax was observed directly from data as time of first occurrence.

    Measured: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

  7. Terminal Phase Half-Life (t1/2) of PF-07817883

    Terminal half-life was defined as the time measured for the plasma concentration of drug to decrease by one half. t1/2 was determined by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.

    Measured: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

  8. Apparent Clearance (CL/F) of PF-07817883

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by area under the concentration curve from time 0 extrapolated to infinite time (AUCinf).

    Measured: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

  9. Apparent Volume of Distribution (Vz/F) of PF-07817883

    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.

    Measured: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start13 Apr 2023
  3. Primary completion10 Jul 2023
  4. Study completion10 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822440
Sponsor's protocol ID
C5091008
Status last verified
Jul 2024
First submitted
10 Apr 2023
Last updated
4 Oct 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07817883 and Itraconazole in people with Healthy, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) of PF-07817883 (time frame: Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.

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