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

12 Participants Needed

Trial Summary

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.

What data supports the idea that null (also known as: PF-07976016, PF 07976016) is an effective treatment?

The available research does not provide specific data supporting the effectiveness of null (PF-07976016) for its intended condition. The studies mentioned focus on other treatments and conditions, such as femoral neck fracture recovery, cancer therapy evaluation, pediatric intensive care outcomes, geriatric rehabilitation, and IVF stimulation regimens. Therefore, there is no direct evidence from these studies to support the effectiveness of null. ^{1 2 3 4 5}

What safety data is available for the treatment PF-07976016?

The provided research does not contain specific safety data for the treatment PF-07976016 or its alternative names. The titles and abstracts focus on other drugs and general safety databases, but none mention PF-07976016 directly. ^{6 7 8 9 10}

Is the drug PF-07976016 a promising treatment?

The drug PF-07976016 is promising because it targets the p16 gene, which is important for stopping cancer cell growth. Reactivating this gene can help control tumors, making it a valuable option for cancer treatment. ^{11 12 13 14 15}

What is the purpose of this trial?

The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Netherlands 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. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Prediction of three outcome states from pediatric intensive care. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Assembling a toolkit to measure geriatric rehabilitation outcomes. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Is there an ideal stimulation regimen for IVF for poor responders and does it change with age? [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. [2019]

7. England 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. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

10. England pubmed.ncbi.nlm.nih.gov

WITHDRAWN--a resource for withdrawn and discontinued drugs. [2022]

11. England pubmed.ncbi.nlm.nih.gov

p16. [2022]

12. England pubmed.ncbi.nlm.nih.gov

De novo methylation of tumor suppressor gene p16/INK4a is a frequent finding in multiple myeloma patients at diagnosis. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

The p16-specific reactivation and inhibition of cell migration through demethylation of CpG islands by engineered transcription factors. [2022]

14. Greece pubmed.ncbi.nlm.nih.gov

p16INK4a polymorphism: associations with tumour progression in patients with sporadic colorectal cancer. [2004]

15. England pubmed.ncbi.nlm.nih.gov

The INK4A/ARF locus and its two gene products. [2019]