A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, CROSSOVER, FIRST-IN-HUMAN STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-06954522 IN HEALTHY ADULT PARTICIPANTS

The purposes of this study are:

• To see how the new medicine (PF-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. The study will see 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 chosen by chance, like drawing names out of a hat to receive either:

• study medicine (PF-06954522)
• 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. The time frame of the study is approximately up to 36 days for each group and participants will stay at CRU for 20 days.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: PF-06954522; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Clinical Research Unit - New Haven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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).
2. 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.
3. 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.
4. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
5. Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73 m².

6. 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), or bilirubin

     • 1.05 × upper limit of normal (ULN);
   • TSH > ULN;
   • HbA1c ≥6.5%;
   • Hematuria as defined by ≥1+ heme on urine dipstick;
   • Albuminuria as defined by urine albumin/creatinine ratio (UACR) >30 mg/g.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Single dose administration of PF-06954522 and placebo. Participants will receive up to 5 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.	Drug: PF-06954522; PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.; Drug: Placebo; Placebo will be administered as oral suspensions as escalating single doses to be determined.
Experimental: Cohort 2; Single dose administration of PF-06954522 and placebo. Participants will receive up to 4 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.	Drug: PF-06954522; PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.; Drug: Placebo; Placebo will be administered as oral suspensions as escalating single doses to be determined.
Experimental: Cohort 3; Single dose administration of PF-06954522 and placebo. Participants will receive up to 2 dose levels of PF-06954522 and up to 1 dose level of matching placebo.	Drug: PF-06954522; PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.; Drug: Placebo; Placebo will be administered as oral suspensions as escalating single doses to be determined.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Following Single Ascending Dose	Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
Number of Participants with Clinical Laboratory Abnormalities	Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
Number of Participants with Clinically Significant Change from Baseline in Vital Signs	Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings	Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings	Day 1 in each period for approximately 8 hours (each period is 7 days) up to approximately 36 days
Number of Participants with Clinically Significant Change from Baseline in Physical Examination Findings	Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of PF-06954522	Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06954522	Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06954522	Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06954522	Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
Plasma Half-Life (t1/2) of PF-06954522	Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: C4001001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No