HealthyPhase 1NCT05431153

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

A Phase 1 study testing Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) and Single dose of PF-07104091 as Tablet Formulation C (Treatment C) 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

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation B (Treatment B) and Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 10 Jun 2022to 17 Oct 2022
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 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

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, 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

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.

Conditions: Healthy
Being tested: Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation B (Treatment B), Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Single dose of PF-07104091 as Tablet Formulation D (Treatment D), Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
Keywords: PF-07104091, Food-effect, Relative Bioavailability, Pharmacokinetics, Cyclin-Dependent Kinase 2 (CDK2) inhibitor

What participants receive

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

Single dose of PF-07104091 as Tablet Formulation A (Treatment A)Drug
Also called Tablet Formulation A, Fasted
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)Drug
Also called Tablet Formulation B, Fasted
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)Drug
Also called Tablet Formulation C, Fasted
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)Drug
Also called Tablet Formulation D, Fasted
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)Drug
Also called Tablet Formulation C, Fed
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.

Study groups in NCT05431153
Study group	Role	What they receive
PF-07104091 Sequence 1	Experimental	Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth. Receives: Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A); Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C); Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
PF-07104091 Sequence 2	Experimental	Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth. Receives: Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A); Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C); Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
PF-07104091 Sequence 3	Experimental	Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth. Receives: Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A); Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C); Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
PF-07104091 Sequence 4	Experimental	Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth. Receives: Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A); Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
PF-07104091 Sequence 5	Experimental	Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth. Receives: Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A); Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
PF-07104091 Sequence 6	Experimental	Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth. Receives: Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A); Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C); Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)

What is being measured

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

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.
Measured: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
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.
Measured: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose

Secondary outcomes (7)

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.
Measured: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-07104091 for Treatment C, D and E
Cmax was maximum observed concentration. Cmax was observed directly from data.
Measured: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
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.
Measured: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
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.
Measured: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
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.
Measured: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
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.
Measured: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
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.
Measured: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)

Timeline

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

10 Jun 202217 Oct 2022

First posted24 Jun 2022
Study start10 Jun 2022
Primary completion17 Oct 2022
Study completion17 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Crossover
Model description: Randomized, open-label, 4-period, 5-treatment, 6-sequence, crossover study.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05431153
Sponsor's protocol ID: C4161007
Status last verified: Oct 2023
First submitted: 9 Jun 2022
Last updated: 8 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05431153
Acronym / sponsor ID: C4161007
Conditions: Healthy
Keywords: PF-07104091, Food-effect, Relative Bioavailability, Pharmacokinetics, Cyclin-Dependent Kinase 2 (CDK2) inhibitor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 10 Jun 2022 (actual)
Primary completion: 17 Oct 2022 (actual)
Study completion: 17 Oct 2022 (actual)
First posted: 24 Jun 2022 (actual)
Results: Posted 8 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: Randomized, open-label, 4-period, 5-treatment, 6-sequence, crossover study.

Arm	Type	Receives
PF-07104091 Sequence 1	Experimental	Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
PF-07104091 Sequence 2	Experimental	Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
PF-07104091 Sequence 3	Experimental	Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
PF-07104091 Sequence 4	Experimental	Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
PF-07104091 Sequence 5	Experimental	Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
PF-07104091 Sequence 6	Experimental	Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C), Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Single dose of PF-07104091 as Tablet Formulation A (Treatment A)Also: Tablet Formulation A, FastedA single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.	Drug	PF-07104091 Sequence 1, PF-07104091 Sequence 2, PF-07104091 Sequence 3, PF-07104091 Sequence 4, PF-07104091 Sequence 5, PF-07104091 Sequence 6
Single dose of PF-07104091 as Tablet Formulation B (Treatment B)Also: Tablet Formulation B, FastedA single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.	Drug	PF-07104091 Sequence 1, PF-07104091 Sequence 2, PF-07104091 Sequence 3, PF-07104091 Sequence 4, PF-07104091 Sequence 5, PF-07104091 Sequence 6
Single dose of PF-07104091 as Tablet Formulation C (Treatment C)Also: Tablet Formulation C, FastedA single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.	Drug	PF-07104091 Sequence 1, PF-07104091 Sequence 2, PF-07104091 Sequence 3, PF-07104091 Sequence 4, PF-07104091 Sequence 5, PF-07104091 Sequence 6
Single dose of PF-07104091 as Tablet Formulation D (Treatment D)Also: Tablet Formulation D, FastedA single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.	Drug	PF-07104091 Sequence 1, PF-07104091 Sequence 2, PF-07104091 Sequence 3
Single dose of PF-07104091 as Tablet Formulation C (Treatment E)Also: Tablet Formulation C, FedA single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.	Drug	PF-07104091 Sequence 4, PF-07104091 Sequence 5, PF-07104091 Sequence 6

Primary outcome

Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C
Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
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.
Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C
Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax was maximum observed concentration. Cmax was observed directly from data.

7 secondary outcomes

AUCinf of PF-07104091 for Treatment C, D and E
Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax of PF-07104091 for Treatment C, D and E
Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Number of Participants With Laboratory Test Abnormalities
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Number of Participants With Clinically Meaningful Findings in Vital Signs
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)

Results and safety

Results posted to the registry on 8 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence ABCD	5	5
Treatment Sequence BCAD	5	5
Treatment Sequence CABD	5	5
Treatment Sequence ABCE	5	5
Treatment Sequence BCAE	5	4
Treatment Sequence CABE	5	5

Primary outcome: Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C

Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanograms*hour per milliliter

Measure	Treatment A: PF-07104091 Tablet Formulation A (Fasted) n = 21	Treatment B: PF-07104091 Tablet Formulation B (Fasted) n = 18	Treatment C: PF-07104091 Tablet Formulation C (Fasted) n = 19
Value	10920 (34)	10720 (28)	11200 (32)

Treatment A: PF-07104091 Tablet Formulation A (Fasted) vs Treatment B: PF-07104091 Tablet Formulation B (Fasted): Ratio of adjusted geometric means: 98.83 (90% CI 94.00 to 103.91)
Treatment A: PF-07104091 Tablet Formulation A (Fasted) vs Treatment C: PF-07104091 Tablet Formulation C (Fasted): Ratio of adjusted geometric means: 98.02 (90% CI 93.88 to 102.35)
Treatment B: PF-07104091 Tablet Formulation B (Fasted) vs Treatment C: PF-07104091 Tablet Formulation C (Fasted): Ratio of adjusted geometric means: 98.51 (90% CI 91.79 to 105.73)

Population analysed: Pharmacokinetic (PK) Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C

Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanograms per milliliter

Measure	Treatment A: PF-07104091 Tablet Formulation A (Fasted) n = 27	Treatment B: PF-07104091 Tablet Formulation B (Fasted) n = 28	Treatment C: PF-07104091 Tablet Formulation C (Fasted) n = 27
Value	1531 (31)	1490 (28)	1415 (34)

Treatment A: PF-07104091 Tablet Formulation A (Fasted) vs Treatment B: PF-07104091 Tablet Formulation B (Fasted): Ratio of adjusted geometric means: 96.35 (90% CI 87.48 to 106.12)
Treatment A: PF-07104091 Tablet Formulation A (Fasted) vs Treatment C: PF-07104091 Tablet Formulation C (Fasted): Ratio of adjusted geometric means: 93.47 (90% CI 85.65 to 102.00)
Treatment B: PF-07104091 Tablet Formulation B (Fasted) vs Treatment C: PF-07104091 Tablet Formulation C (Fasted): Ratio of adjusted geometric means: 98.01 (90% CI 89.86 to 106.90)

Population analysed: PK Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: PF-07104091 Tablet Formulation A (Fasted)	0 of 29 (0%)	21 of 29 (72.4%)	0 of 29
Treatment B: PF-07104091 Tablet Formulation B (Fasted)	0 of 30 (0%)	18 of 30 (60%)	0 of 30
Treatment C: PF-07104091 Tablet Formulation C (Fasted)	0 of 29 (0%)	17 of 29 (58.6%)	0 of 29
Treatment D: PF-07104091 Tablet Formulation D (Fasted)	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15
Treatment E: PF-07104091 Tablet Formulation C (Fed)	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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 8 Apr 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 8 Apr 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?

Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C (time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose). 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?

On the ClinicalTrials.gov record for NCT05431153.

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 8 Apr 2024.