12 Participants Needed

PF-07976016 Formulations for Healthy Adults

PC
Overseen ByPfizer CT.gov Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.1112131415

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

PC

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
See 4 more

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
2Treatment groups
Experimental Treatment
Group I: Sequence 2Experimental Treatment2 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 1Experimental Treatment2 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.

Find a Clinic Near You

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 profile image

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

References

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]
An analysis for transient states with application to tumor shrinkage. [2006]
Prediction of three outcome states from pediatric intensive care. [2019]
Assembling a toolkit to measure geriatric rehabilitation outcomes. [2019]
Is there an ideal stimulation regimen for IVF for poor responders and does it change with age? [2022]
The OptiMARK clinical development program: summary of safety data. [2019]
Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. [2023]
Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. [2018]
Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]
WITHDRAWN--a resource for withdrawn and discontinued drugs. [2022]
p16. [2022]
De novo methylation of tumor suppressor gene p16/INK4a is a frequent finding in multiple myeloma patients at diagnosis. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
The p16-specific reactivation and inhibition of cell migration through demethylation of CpG islands by engineered transcription factors. [2022]
p16INK4a polymorphism: associations with tumour progression in patients with sporadic colorectal cancer. [2004]
The INK4A/ARF locus and its two gene products. [2019]
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