Study Medicine for Healthy Adults

Recruiting at 1 trial location

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: CYP3A inducers/inhibitors

Disqualifiers: Renal impairment, Hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 11 days per period

23 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or nonprescription drugs, dietary, and herbal supplements at least 7 days or 5 half-lives before the first dose of the study medicine, whichever is longer. Certain medications affecting liver enzymes (CYP3A inducers or inhibitors) must be stopped 14 days plus 5 half-lives before the study.

What is the purpose of this trial?

This trial tests a new drug called PF-07853578 on adults to see if they can handle it without major issues. Researchers will measure side effects and how much of the drug enters the bloodstream.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Inclusion Criteria

BMI of 16 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73m².

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending oral doses of PF-07853578 or placebo

11 days per period

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

29-36 days post final dose

Treatment Details

Interventions

• PF-07853578
• Placebo

Participant Groups

Group I: Cohort 3 Experimental Treatment 2 Interventions

Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.

Group II: Cohort 2 Experimental Treatment 2 Interventions

Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.

Group III: Cohort 1 Experimental Treatment 2 Interventions

Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.

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