Clinical trial NCT04857437: Study in Healthy Adults Evaluating PF-07202954
Official title: A PHASE 1, 3-PART, SPONSOR OPEN STUDY OF PF-07202954 IN HEALTHY ADULTS: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TO ASSESS SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE (IN PART 1), AND REPEATED (IN PART 2), ESCALATING, ORAL DOSES ALONG WITH CONDITIONAL PART 3 OF RANDOMIZED, OPEN-LABEL ASSESSMENT OF EFFECT OF FOOD ON PF-07202954 EXPOSURE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Alcoholic Fatty Liver Disease
Liver Fibrosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 12
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 study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).


Eligibility criteria: Inclusion Criteria:- healthy subjects (all 3 Parts)

* evidence of steatosis on FibroScan (Part 2 only)
* BMI 17.5 to 30.5 kg/m2 (Part 1, Part 3)
* BMI 17.5 to 35.4 kg/m2 (Part 2) Exclusion Criteria:- evidence of clinically significant disease
* subjects on chronic medications
* clinically significant, abnormal laboratory results, vital signs, or cardiac conduction abnormalities
* contraindication to MRI (Part 2, only)

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1
timeFrame: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)
measure: Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 1
timeFrame: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)
measure: Number of Participants According to Categorization of Vital Signs Data: Part 1
timeFrame: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)
measure: Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1
timeFrame: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)
measure: Number of Participants With TEAEs: Part 2
timeFrame: Up to a maximum of 12 weeks
measure: Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 2
timeFrame: Up to a maximum of 12 weeks
measure: Number of Participants According to Categorization of Vital Signs Data: Part 2
timeFrame: Up to a maximum of 12 weeks
measure: Number of Participants According to Categorization of ECG Data: Part 2
timeFrame: Up to a maximum of 12 weeks
measure: Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 3
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
measure: Time for Cmax (Tmax) of PF-07202954: Part 3
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
measure: Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 3
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
measure: Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 3
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
measure: Time for Cmax (Tmax) of PF-07202954: Part 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
measure: Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
measure: Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
measure: Terminal Half-life (t1/2) of PF-07202954: Part 1
timeFrame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
measure: Maximum Observed Plasma Concentration (Cmax) of PF-07202954 on Day 1, 7 and 14: Part 2
timeFrame: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
measure: Time for Cmax (Tmax) of PF-07202954 on Day 1, 7 and 14: Part 2
timeFrame: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
measure: Area Under the Plasma Concentration-time Profile From Time 0 to Time Tau (AUCtau) of PF-07202954 on Day 1, 7 and 14: Part 2
timeFrame: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
measure: Terminal Half-life (t1/2) of PF-07202954 on Day 14: Part 2
timeFrame: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
measure: Amount of Unchanged Drug Recovered in Urine During Dosing Interval (Aetau) of PF-07202954 on Day 14: Part 2
timeFrame: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
measure: Percent of Dose Recovered in Urine as Unchanged Drug Over Dosing Interval (Aetau%) on Day 14: Part 2
timeFrame: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
measure: Renal Clearance (CLr) of PF-07202954 on Day 14: Part 2
timeFrame: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
measure: Number of Participants With TEAEs: Part 3
timeFrame: Up to maximum of 6 weeks
measure: Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 3
timeFrame: Up to maximum of 6 weeks
measure: Number of Participants According to Categorization of Vital Signs Data: Part 3
timeFrame: Up to maximum of 6 weeks
measure: Number of Participants According to Categorization of ECG Data: Part 3
timeFrame: Up to maximum of 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: