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Healthy ParticipantsPhase 1NCT04124653

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants

A Phase 1 study testing PF-06842874 and Relative Bioavailability in people with Healthy Participants, run by Pfizer at 2 sites 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

This study will be the first time PF-06842874 is administered to humans. The purpose of Part A of the study is to investigate the safety, tolerability, and pharmacokinetics of PF-06842874 following administration of single oral doses as an immediate-release or modified-release formulation to healthy adult… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
PF-06842874 and Relative Bioavailability
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
2 sitesUnited States
Study dates
17 Oct 2019to 26 Jul 2021
Phase
Phase 1
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female participants of non-childbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, and cardiac monitoring.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  • Any condition possibly affecting drug absorption.
  • History of human immunodeficiency virus infection (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
  • Participants with benign ethnic neutropenia or cyclic neutropenia.
  • Other acute or chronic medical or psychiatric condition.
  • 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 investigational product.
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  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
  • A positive urine drug test.
  • Screening supine blood pressure (BP) ≥140 mmHg (systolic) or ≥90 mmHg (diastolic), following at least 5 minutes of supine rest.
  • Baseline 12-lead standard electrocardiogram (ECG) that demonstrates clinically relevant abnormalities.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.25× upper limit of normal (ULN); total bilirubin level ≥1.5× ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ULN; hemoglobin ≤14 gm/dL (males) and ≤13 gm/dL (females); neutrophils <1500 cells/mm3.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

  • Pfizer New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-06842874 ADMINISTERED AS AN IMMEDIATE-RELEASE OR MODIFIED-RELEASE FORMULATION TO HEALTHY ADULT PARTICIPANTS AND AN OPEN-LABEL ASSESSMENT OF THE RELATIVE BIOAVAILABILITY OF A MODIFIED-RELEASE FORMULATION OF PF-06842874

This study will be the first time PF-06842874 is administered to humans. The purpose of Part A of the study is to investigate the safety, tolerability, and pharmacokinetics of PF-06842874 following administration of single oral doses as an immediate-release or modified-release formulation to healthy adult participants. Part B of this study will evaluate the relative bioavailability of a modified-release formulation of PF-06842874 for its potential use in future clinical studies. The effect of food on PF-06842874 pharmacokinetics may also be evaluated in this study.

Being tested
PF-06842874, Placebo, Relative Bioavailability
Keywords
PF-06842874, first in human, cyclin-dependent kinase 4, cyclin-dependent kinase 6, CDK4/6, healthy participants, immediate release, modified release, relative bioavailability

What participants receive

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

  • PF-06842874Drug

    Single dose administration of PF-06842874

  • PlaceboDrug

    Single dose administration of placebo

  • Relative BioavailabilityDrug

    Relative bioavailability assessment of modified-release formulation

Study groups in NCT04124653
Study groupRoleWhat they receive
PF-06842874/PlaceboExperimentalSingle dose administration of PF-06842874 or placebo
Receives: Drug: PF-06842874; Drug: Placebo
Relative BioavailabilityExperimentalDetermination of relative bioavailability of modified-release formulation relative to immediate-release formulation
Receives: Drug: Relative Bioavailability

What is being measured

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

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Treatment-related AEs are any untoward medical occurrences attributed to study drug in a participant who received study drug.

    Measured: Baseline up to 35 days after last dose of study medication

  2. Number of Participants With Clinical Laboratory Abnormalities

    The following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).

    Measured: Baseline up to 10 days after last dose of study medication

  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    The following parameters will be analyzed for examination of vital signs: systolic blood pressure, diastolic blood pressure, and pulse rate.

    Measured: 0, 1, 2, 3, 5, 8, 12, 24, and 48 hours post-dose

  4. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings

    Measurements of heart rate, PR interval, QT interval, QTc intervals, and QRS complex

    Measured: 0, 1, 2, 3, 5, 8, 12, 24, and 48 hours post-dose

  5. Abnormal rhythms as observed continuous cardiac monitoring

    Cardiac rhythms measured by continuous cardiac telemetry

    Measured: 0 to 8 hours post-dose

  6. Number of Participants With Clinically-Significant Change From Baseline in Physical Examination Findings

    A complete physical examination includes, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A limited physical examination includes, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms.

    Measured: Baseline up to 10 days after last dose of study medication

Secondary outcomes (5)

  1. Maximum Observed Plasma Concentration (Cmax) of PF-06842874

    Maximum observed plasma concentration for immediate-release and modified-release formulations of PF-06842874

    Measured: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose

  2. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06842874

    Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for immediate-release and modified-release formulations of PF-06842874

    Measured: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose

  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06842874

    Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0-inf) for immediate-release and modified-release formulations of PF-06842874. It is obtained from AUC(0-t) plus AUC (t-inf).

    Measured: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06842874

    Time to reach maximum observed plasma concentration for immediate-release and modified-release formulations of PF-06842874

    Measured: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose

  5. Plasma Half-Life (t1/2) of PF-06842874

    Plasma half-life is the time measured for the plasma concentration to decrease by one half for immediate-release and modified-release formulations of PF-06842874.

    Measured: 0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, and 48 hours post-dose

Timeline

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

  1. First posted11 Oct 2019
  2. Study start17 Oct 2019
  3. Primary completion26 Jul 2021
  4. Study completion26 Jul 2021

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04124653
Sponsor's protocol ID
C4041001
Status last verified
Dec 2021
First submitted
10 Oct 2019
Last updated
6 Dec 2021
Results posted
No
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-06842874 and Relative Bioavailability in people with Healthy Participants, run by Pfizer at 2 sites 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 15 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 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) (time frame: Baseline up to 35 days after last dose of study medication). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04124653.

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 6 Dec 2021.

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