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PF-07328948 oral tablet and oral suspension (Cohort 9) for Healthy

New Haven Clinical Research Unit, New Haven, CT
HealthyPF-07328948 - Drug
Eligibility
18 - 60
All Sexes

Study Summary

This trial studies the safety, effectiveness of a new drug, given as a pill or suspension, to healthy participants. It includes 2 parts with up to 12 weeks for each.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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1
Everolimus Oral Tablet
1
JNJ-68179280
1
T1

Study Objectives

9 Primary · 14 Secondary · Reporting Duration: predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on Day 14

Day 14
Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry
Week 7
Part A: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Part A: Number of Participants With Change From Baseline in Physical Examination Findings
Part A: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Week 7
Part A: Number of Participants With Clinical Laboratory Abnormalities
Week 11
Part A: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Day 35
Part B: Number of Participants With Clinically-Significant Change From Baseline in Physical Examination Findings
Part B: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Day 4
Part B: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Part B: Number of Participants With Clinical Laboratory Abnormalities
Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Day 14
Part A: Amount of PF-07328948 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
Part A: Percentage of Dose of PF-07328948 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)
Day 14
Part A: Renal Clearance of PF-07328948
Day 1
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to Extrapolated Infinite Time (AUCinf) of PF-07328948 Tablet Formation and Oral Suspension
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07328948 Tablet Formation and Oral Suspension
Part B: Maximum Observed Plasma Concentration (Cmax) of PF-07328948 Tablet Formation and Oral Suspension
Day 14
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (tau) (AUCtau) of PF-07328948
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07328948
Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07328948
Day 1
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to Extrapolated Infinite Time (AUCinf) of PF-07328948 Tablet Formation Under Fasted and Fed Condition
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07328948 Tablet Formation Under Fasted and Fed Condition
Part B: Maximum Observed Plasma Concentration (Cmax) of PF-07328948 Tablet Formation Under Fasted and Fed Condition

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Everolimus Oral Tablet
1
JNJ-68179280
1
T1

Trial Design

9 Treatment Groups

PF-07328948 and Placebo (Cohort 6)
1 of 9
PF-07328948 and Placebo (Cohort 2)
1 of 9
PF-07328948 oral tablet and oral suspension (Cohort 9)
1 of 9
PF-07328948 and Placebo (Cohort 4)
1 of 9
PF-07328948 and Placebo (Cohort 7)
1 of 9
PF-07328948 and Placebo (Cohort 3)
1 of 9
PF-07328948 and Placebo (Cohort 5)
1 of 9
PF-07328948 and Placebo (Cohort 1)
1 of 9
PF-07328948 and Placebo (Cohort 8)
1 of 9

Experimental Treatment

88 Total Participants · 9 Treatment Groups

Primary Treatment: PF-07328948 oral tablet and oral suspension (Cohort 9) · Has Placebo Group · Phase 1

PF-07328948 and Placebo (Cohort 6)Experimental Group · 2 Interventions: Placebo, PF-07328948 · Intervention Types: Drug, Drug
PF-07328948 and Placebo (Cohort 2)Experimental Group · 2 Interventions: Placebo, PF-07328948 · Intervention Types: Drug, Drug
PF-07328948 oral tablet and oral suspension (Cohort 9)
Drug
Experimental Group · 1 Intervention: PF-07328948 · Intervention Types: Drug
PF-07328948 and Placebo (Cohort 4)Experimental Group · 2 Interventions: Placebo, PF-07328948 · Intervention Types: Drug, Drug
PF-07328948 and Placebo (Cohort 7)Experimental Group · 2 Interventions: Placebo, PF-07328948 · Intervention Types: Drug, Drug
PF-07328948 and Placebo (Cohort 3)Experimental Group · 2 Interventions: Placebo, PF-07328948 · Intervention Types: Drug, Drug
PF-07328948 and Placebo (Cohort 5)Experimental Group · 2 Interventions: Placebo, PF-07328948 · Intervention Types: Drug, Drug
PF-07328948 and Placebo (Cohort 1)Experimental Group · 2 Interventions: Placebo, PF-07328948 · Intervention Types: Drug, Drug
PF-07328948 and Placebo (Cohort 8)Experimental Group · 2 Interventions: Placebo, PF-07328948 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
PF-07328948
2022
Completed Phase 1
~20

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on day 14

Who is running the clinical trial?

PfizerLead Sponsor
4,406 Previous Clinical Trials
25,778,794 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,346 Previous Clinical Trials
23,431,066 Total Patients Enrolled

Eligibility Criteria

Age 18 - 60 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Are there any age restrictions on who may participate in this experiment?

"As specified in the study requirements, only persons aged 18 or higher but below 60 may take part." - Anonymous Online Contributor

Unverified Answer

Can I qualify for the experiment?

"Candidates for this trial must fulfil the requirement of being between 18 and 60 years old and in good health. The number of participants that will be accepted totals 88 individuals." - Anonymous Online Contributor

Unverified Answer

Do the doors to this research program remain open for new participants?

"This investigation is still open to potential participants, as indicated by the data posted on clinicaltrials.gov. The trial was first made available on April 5th 2023 and has been updated most recently on April 21st of this same year." - Anonymous Online Contributor

Unverified Answer

What is the standing of PF-07328948 oral tablet and suspension (Cohort 9) in regards to regulatory acceptance?

"Due to the limited safety and efficacy data demonstrated in Phase 1, our team assigned PF-07328948 oral tablet/suspension (Cohort 9) a score of 1 on our scale from 1 to 3." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment number for this research endeavor?

"Affirmative, the details provided on clinicaltrials.gov signify that this research is actively recruiting volunteers. This study was posted to the website on April 5th 2023 and had its last update occur two weeks later. For completion of this trial, 88 patients need to be recruited from a single centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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