PF-07976016 Formulations for Healthy Adults

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Prescription drugs

Disqualifiers: HIV, HepB, HepC, alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the body absorbs two different versions of the drug PF-07976016. The goal is to measure and compare the drug's concentration in the blood after a single dose of each version. Participants are divided into two groups, taking one version first and then the other, with a week between doses. The trial suits adults who are generally healthy, weigh over 110 pounds, and do not have conditions affecting drug absorption. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications?

Yes, you must stop taking prescription or non-prescription drugs within a specified timeframe before the study starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-07976016 has undergone safety testing in humans. One study found it to be safe and effective. However, concerns exist because a similar drug encountered potential liver safety issues, halting its development. This necessitates caution, as liver problems were identified in that instance.

The current trial is in an early stage, meaning researchers are still assessing how well people tolerate PF-07976016. Early trials primarily focus on ensuring the treatment's safety. Participants might experience some side effects, but researchers monitor these closely.

Overall, while some safety information is available, it remains early for PF-07976016. Prospective participants should be aware of this and discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07976016 because it offers a potentially innovative approach to treatment. Unlike current options that primarily focus on symptom management, PF-07976016 is being explored for its unique formulation that might improve how the body absorbs and utilizes the drug. This could lead to faster or more efficient results. Additionally, the study explores different sequences of dosing, which may help optimize treatment outcomes and minimize side effects. Overall, these features could represent a significant advancement in therapeutic strategies.

What evidence suggests that this trial's treatments could be effective?

Research on PF-07976016 focuses on understanding how the drug is absorbed and processed in the body. In this trial, participants will receive different formulations of PF-07976016 to test absorption in healthy individuals. The main goal is to determine how much of the drug enters the bloodstream after administration. Early studies have examined various forms of the drug to identify the most effective absorption method. The current focus ensures the drug functions as expected in the body, which is crucial for its future use. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This clinical trial is for healthy adults. Specific eligibility criteria are not provided, but typically participants should have no significant medical conditions and be within a certain age range.

Inclusion Criteria

Willing to provide consent and follow study requirements

I weigh more than 110lbs (50kg).

I am generally healthy based on recent medical exams and tests.

Exclusion Criteria

Serious illness or hospitalization, or other condition, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study

I do not have HIV, Hepatitis B, or Hepatitis C.

Positive urine drug test at screening/admission

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of PF-07976016 in up to 3 study periods with a 7-day washout period between doses

3-4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07976016

Trial Overview

The study is testing how two different forms of a drug called PF-07976016 are absorbed into the bloodstream after a single dose. The goal is to measure and compare the levels of the drug in blood between Formulation A and Formulation B.

How Is the Trial Designed?

Group I: Sequence 2 Experimental Treatment 2 Interventions

Participants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period.

Group II: Sequence 1 Experimental Treatment 2 Interventions

Participants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Engineered p16-specific artificial transcription factors (p16ATFs) can selectively reactivate the expression of the p16 tumor suppressor gene in cancer cells, demonstrating a targeted approach to gene therapy.

The use of p16ATFs led to demethylation of the p16 promoter and inhibited cancer cell migration and invasion, suggesting a potential therapeutic strategy that minimizes side effects compared to traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The p16-specific reactivation and inhibition of cell migration through demethylation of CpG islands by engineered transcription factors. Zhang, B., Xiang, S., Zhong, Q., et al.[2022]

The proposed method of summarizing improvement in chronic disease therapies focuses on the probability of being in response over time, which combines multiple endpoints into a single, interpretable measure.

This approach, demonstrated with data from a cancer clinical trial, accounts for censored observations and provides a clearer understanding of treatment efficacy compared to traditional methods that evaluate frequency or duration separately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis for transient states with application to tumor shrinkage. Temkin, NR.[2006]

A new toolkit of eight measurement instruments was developed to assess various aspects of functioning and activity performance in older adults, covering areas like mobility, daily living activities, and social functioning.

The toolkit was well-received by 22 older adult participants, who completed the assessments in two sessions, indicating its feasibility for use in clinical and research settings, although some measures, like social functioning, showed a ceiling effect that may limit their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assembling a toolkit to measure geriatric rehabilitation outcomes. Demers, L., Desrosiers, J., Ska, B., et al.[2019]

In a study analyzing 1,608 cycles from 'poor' responders and 8,489 cycles from 'non poor' responders, no significant differences were found in fertilization or embryo utilization rates across different stimulation regimens for 'poor' responders.

'Non poor' responders had significantly higher pregnancy rates per initiated cycle compared to 'poor' responders, indicating that treatment effectiveness varies greatly between these two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there an ideal stimulation regimen for IVF for poor responders and does it change with age? Vollenhoven, B., Osianlis, T., Catt, J.[2022]

The INK4A/ARF locus on chromosome 9 is frequently mutated in human cancers, highlighting its significance in cancer biology.

The genes p16(INK4a) and p19(ARF), which are encoded at this locus, are crucial for regulating cell growth, survival, and the aging process of cells, indicating their potential as targets for cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The INK4A/ARF locus and its two gene products. Sharpless, NE., DePinho, RA.[2019]

In a clinical development program involving 1684 subjects and 2038 injections, OptiMARK demonstrated a safety profile comparable to Magnevist, with 31% of its injections associated with adverse events.

OptiMARK was found to be safe and well-tolerated, showing fewer adverse events compared to Magnevist (35%) and placebo (48%), indicating its potential as a reliable imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. Brown, JJ., Kristy, RM., Stevens, GR., et al.[2019]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

The WITHDRAWN database catalogs 578 drugs that have been withdrawn or discontinued, focusing on their structures, properties, and reasons for withdrawal, particularly adverse drug reactions.

About half of the drugs in the database were withdrawn primarily due to safety issues, highlighting the importance of understanding toxicity mechanisms in drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN--a resource for withdrawn and discontinued drugs. Siramshetty, VB., Nickel, J., Omieczynski, C., et al.[2022]

In a study of 101 untreated multiple myeloma (MM) patients and five primary plasma cell leukemia (PCL) patients, 40.5% of MM patients and 80% of PCL patients exhibited hypermethylation of the p16 gene, indicating a significant prevalence of this genetic alteration in these blood cancers.

The hypermethylation of the p16 gene, which inhibits cell cycle regulation, suggests a mechanism by which this gene's inactivation contributes to the development of multiple myeloma and primary plasma cell leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De novo methylation of tumor suppressor gene p16/INK4a is a frequent finding in multiple myeloma patients at diagnosis. González, M., Mateos, MV., García-Sanz, R., et al.[2019]

The study found that specific polymorphisms in the p16INK4a gene, particularly the GG(442) and CC(500) genotypes, are linked to worse tumor differentiation and more advanced stages of colorectal cancer (CRC) in patients, suggesting these genetic variations may serve as markers for tumor progression.

Patients with the CC(500) genotype also exhibited reduced expression of the p16INK4a protein, indicating that this polymorphism may influence both the genetic and protein levels of p16INK4a, potentially impacting tumor behavior in sporadic CRC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

p16INK4a polymorphism: associations with tumour progression in patients with sporadic colorectal cancer. McCloud, JM., Sivakumar, R., Greenhough, A., et al.[2004]

A new predictive model developed for pediatric intensive care can effectively classify patient outcomes as functional, compromised, or dead based on admission data from 1,663 patients, using factors like the Pediatric Risk of Mortality score and baseline functional status.

The model demonstrated high accuracy in a validation sample of 1,153 patients, achieving correct classification rates of 83.2% for functional, 74.4% for compromised, and 81.3% for death outcomes, indicating its potential to enhance quality of care assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of three outcome states from pediatric intensive care. Ruttimann, UE., Pollack, MM., Fiser, DH.[2019]

The p16 gene is a crucial tumor suppressor, second only to p53, and plays a significant role in distinguishing between different types of melanoma, with strong nuclear positivity indicating desmoplastic melanoma.

p16 immunohistochemistry is also important for identifying HPV-associated tumors, as overexpression of p16 is a marker of infection, and it can help in diagnosing malignant mesothelioma and certain types of liposarcoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

p16. Serra, S., Chetty, R.[2022]

A safety analysis of ubrogepant and rimegepant, based on 2010 and 3691 adverse event reports respectively, identified 10 and 25 significant safety signals, indicating potential risks associated with these medications.

The adverse events reported were primarily related to psychiatric, neurological, gastrointestinal, skin, vascular, and infectious issues, highlighting the need for further research to confirm these safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. Battini, V., Carnovale, C., Clementi, E., et al.[2023]

The Drug Adverse Reaction Database (DART) provides detailed information on 147 confirmed and 89 potential protein targets associated with adverse drug reactions (ADRs), which is crucial for understanding the mechanisms behind these reactions and aiding in drug discovery.

DART includes extensive data on 257 drugs and 1080 ligands, offering insights into their binding properties, physiological functions, and the specific adverse effects they may cause, making it a valuable resource for researchers and developers in pharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. Ji, ZL., Han, LY., Yap, CW., et al.[2018]

In a study of 182 patients aged 20-69 with femoral neck fractures treated with internal fixation, 73% of those with displaced fractures and 85% with non-displaced fractures reported good or excellent functional outcomes at 24 months.

Despite a significant percentage achieving good functional outcomes, patients did not fully regain their pre-fracture health-related quality of life, indicating that while surgical intervention is effective, it may not restore overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. Campenfeldt, P., Hedström, M., Ekström, W., et al.[2018]

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