← Back to Search

Part A Optional Cohort 4 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A total body weight >50 kg (110 lb).
Key
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 7 and 14
Awards & highlights

Study Summary

This trial will test if a study medicine is safe & how it is absorbed in healthy & obese people, and if it interacts with another medicine.

Who is the study for?
This trial is for healthy adults aged 18 to 65 who weigh more than 110 pounds. Participants should have a BMI of 20-33 kg/m2, or for one part of the study, a BMI of 30-40 kg/m2 with well-controlled high blood lipids or blood pressure. They must be in good health as confirmed by medical exams and tests.Check my eligibility
What is being tested?
The trial is testing PF-07976016 to see if it's safe and how it moves through the body when taken by healthy people. It will also check if this medicine affects or is affected by another drug called midazolam, especially in individuals with obesity.See study design
What are the potential side effects?
Possible side effects are not detailed but typically include reactions at the site where the drug was given, changes in liver enzymes (detected by blood tests), tiredness, headache, nausea, and other common drug-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh more than 110 pounds.
Select...
It looks like there might be a typo in your request. Could you please provide more context or clarify the criterion you'd like to have summarized?

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 7 and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 7 and 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Number of Participants With Clinical Laboratory Abnormalities Following Single Doses
Part A: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses
Part A: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Single Doses
+5 more
Secondary outcome measures
Part A: Area Under the Curve From Time Zero to Extrapolated Infinite Time
Part A: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration
Part A: Maximum Observed Plasma Concentration
+16 more

Trial Design

13Treatment groups
Experimental Treatment
Group I: Part D Optional Cohort 13Experimental Treatment2 Interventions
Multiple dose administration of PF-07976016 or matching placebo.
Group II: Part C Optional Cohort 12Experimental Treatment2 Interventions
Single dose midazolam administered alone or in combination with multiple doses of PF-07976016.
Group III: Part C Optional Cohort 11Experimental Treatment2 Interventions
Single dose midazolam administered alone or in combination with multiple doses of PF-07976016.
Group IV: Part B Optional Cohort 10Experimental Treatment2 Interventions
Multiple dose administration of PF-07976016 or matching placebo.
Group V: Part B Cohort 9Experimental Treatment2 Interventions
Multiple dose administration of PF-07976016 or matching placebo.
Group VI: Part B Cohort 8Experimental Treatment2 Interventions
Multiple dose administration of PF-07976016 or matching placebo.
Group VII: Part B Cohort 7Experimental Treatment2 Interventions
Multiple dose administration of PF-07976016 or matching placebo.
Group VIII: Part B Cohort 6Experimental Treatment2 Interventions
Multiple dose administration of PF-07976016 or matching placebo.
Group IX: Part B Cohort 5Experimental Treatment2 Interventions
Multiple dose administration of PF-07976016 or matching placebo.
Group X: Part A Optional Cohort 4Experimental Treatment2 Interventions
Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Group XI: Part A Optional Cohort 3Experimental Treatment2 Interventions
Single dose administration of PF-07976016 and placebo. Participants will receive up to 2 dose levels of PF-07976016 or matching placebo.
Group XII: Part A Cohort 2Experimental Treatment2 Interventions
Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Group XIII: Part A Cohort 1Experimental Treatment2 Interventions
Single dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Midazolam
2018
Completed Phase 4
~1910

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,836 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,054 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment available for this research?

"To meet the requirements of this clinical trial, prospective participants must be aged between 18 and 65 years old with no current medical issues. 146 individuals are yet to be enrolled in the study."

Answered by AI

To what extent can Part D Optional Cohort 13 be detrimental to individuals?

"Our assessment at Power has given Part D Optional Cohort 13 a score of 1, reflecting the limited evidence to support its safety and effectiveness."

Answered by AI

Are volunteers being enrolled in this clinical experiment at present?

"Affirmative. Clinicaltrials.gov's records show that this clinical trial, which was initially posted on October 27th 2023, is actively enrolling patients. The study requires 146 participants from a single medical centre to complete the research."

Answered by AI

Does this research opportunity extend to those under the age of twenty?

"This experiment is limited to individuals aged 18-65 years old. Moreover, there are 62 distinct trials available for minors and 395 for elderly patients."

Answered by AI

What is the participant capacity for this medical experiment?

"Indeed, clinicaltrials.gov's data confirms that this research is currently seeking volunteers; the trial was initially posted on October 27th 2023 and most recently updated on December 1st 2023. The objective is to recruit 146 patients from a single medical site."

Answered by AI

Who else is applying?

What site did they apply to?
Pfizer Clinical Research Unit - New Haven
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have been doing clinical trials.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Learn How Different Amounts of the Study Medicine Called PF-07976016 Are Tolerated and Act in The Body in Healthy Adults
2023. "A Study to Learn How Different Amounts of the Study Medicine Called PF-07976016 Are Tolerated and Act in The Body in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106009.
~58 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top