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

• ClinicalTrials.gov Identifier: NCT06003777
• Recruitment Status: Completed
• First Posted: August 22, 2023
• Last Update Posted: March 6, 2024
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: August 3, 2023
• First Posted Date: August 22, 2023
• Last Update Posted Date: March 6, 2024
• Actual Study Start Date: August 30, 2023
• Actual Primary Completion Date: February 20, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2023)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Following Single Ascending Dose [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 15, 2023)

• Maximum Observed Plasma Concentration (Cmax) of PF-06954522 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy Participants

Intervention

• 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.

Study Arms

• 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.
  Interventions:

  • Drug: PF-06954522
  • Drug: Placebo
• 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.
  Interventions:

  • Drug: PF-06954522
  • Drug: Placebo
• 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.
  Interventions:

  • Drug: PF-06954522
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 16, 2024): 26
• Original Estimated Enrollment (submitted: August 15, 2023): 24
• Actual Study Completion Date: February 20, 2024
• Actual Primary Completion Date: February 20, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06003777
• Other Study ID Numbers: C4001001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• 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.

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2024