A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults

NCT05890105 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C5161001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

The purposes of this study are:

• To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects. And, how people feel after taking single increasing amount of the medicine by mouth.
• To measure the amount of study medicine in your blood after the medicine is taken by mouth. This study is seeking for participants who:
• are females of 18 to 65 years old and are not able to give birth to a child.
• are males of 18 to 65 years old.
• have body mass index of 16 to 31 kilograms per meter squared.
• have a total body weight of more than 50 kilograms (110 pounds). Participants will be randomly selected to receive either study medicine (PF-07853578) or placebo (a pill that has no medicine in it). Participants may receive up to 4 amounts of study medicine and up to 2 amounts of placebo.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Day 1-11 in each period, along with the 29-36 day post final dose follow-up

• Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality

  Pre-defined categorical criteria for laboratory abnormalities included: Lymphocytes \<0.8 x lower limit of normal (LLN); Basophils/Leukocytes \> 1.2 x upper limit of normal (ULN); Eosinophils/Leukocytes \>1.2 x ULN; Monocytes/Leukocytes \>1.2 x ULN; low-density lipoprotein (LDL) Direct Endpoint Measure \>1.2 x ULN; Triglycerides \>1.3 x ULN; Specific Gravity \<1.003 or \>1.030; pH \>8; Ketones ≥1; Urobilinogen (EU) ≥1; URINE Bilirubin ≥1; Leukocyte Esterase ≥1.

  Day 1-11 in each period, along with the 29-36 day post final dose follow-up

• Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria

  Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.

  Day 1-11 in each period, along with the 29-36 day post final dose follow-up

• Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria

  ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is \> 200 msec, c) ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and ≤480 msec, b) \>480 msec and ≤500 msec, c) \>500 msec, d) \>30 msec and ≤60 msec increase from baseline, e) \>60 msec increase from baseline.

  Day 1-11 in each period, along with the 29-36 day post final dose follow-up

Secondary Outcomes (5)

• Maximum Concentration Observed in Plasma (Cmax)

  Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)

• Time to Achieve Cmax (Tmax)

  Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)

• Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast)

  Pre-dose (0 hours) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)

• Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

  Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)

• Terminal Half-Life (t1/2)

  Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)

Study Arms (3)

Cohort 1

EXPERIMENTAL

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.

Drug: PF-07853578; Drug: Placebo

Cohort 2

EXPERIMENTAL

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.

Drug: PF-07853578; Drug: Placebo

Cohort 3

EXPERIMENTAL

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.

Drug: PF-07853578; Drug: Placebo

Interventions

PF-07853578 DRUG

PF-07853578 will be administered as oral solutions or suspensions as escalating single doses to be determined.

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Placebo will be administered as oral solutions or suspensions as escalating single doses to be determined.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants of non-childbearing potential and male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• BMI of 16 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention, with the exception of moderate or strong cytochrome P450 3A (CYP3A) inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
• Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants \<60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
• Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of \<75 mL/min/1.73m².
• Hematuria as defined by \>1+ heme on urine dipstick.
• Albuminuria as defined by albumin/creatine (Cr) ratio on spot urine albumin (UA) \>30 mg/g.
• 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:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), Bilirubin ≥1.05×ULN.
• Total cholesterol, triglycerides, or direct LDL ≥1.25×ULN.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Limitations and Caveats

Any untoward findings identified on physical and/or neurological examinations, and cardiac monitoring conducted during the active collection period were captured as adverse events, if those findings met the definition of an AE.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 6, 2023
• Study Start: June 2, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)