Clinical trial NCT06003777: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Following Single Ascending Dose
timeFrame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
measure: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
timeFrame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
measure: Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings
timeFrame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
measure: Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings
timeFrame: Day 1 in each period for approximately 8 hours (each period is 7 days) up to approximately 36 days
measure: Number of Participants with Clinically Significant Change from Baseline in Physical Examination Findings
timeFrame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06954522
timeFrame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
measure: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06954522
timeFrame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06954522
timeFrame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06954522
timeFrame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
measure: Plasma Half-Life (t1/2) of PF-06954522
timeFrame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: