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OpenTrials
Completed

NCT Number: NCT04857437

Study in Healthy Adults Evaluating PF-07202954

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PF-07202954 Repeat Dose

Drug

10, 30, 100, 300, 600, 1200 milligrams (mg)

PF-07202954 Single Dose

Drug

10, 30, 100, 300, 600, 900, 1200 milligrams (mg)

Placebo

Drug

Matching Placebo

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1

    Time frame: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were AEs that occurred following the start of study treatment (either PF-07202954 or placebo) up to approximately 28 days after the last dose.

  2. Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 1

    Time frame: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

    Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (less than [<] 0.8* lower limit normal [LLN]); monocytes/leukocytes (greater than [>] 1.2* upper limit normal [ULN]); clinical chemistry: low density lipoprotein (LDL) (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (greater than equal to [>=1]), urine erythrocytes (>= 20), red blood cells (RBC) casts (>1), bacteria (>20). Number of participants with any laboratory abnormality meeting pre-defined criteria was reported in this outcome measure.

  3. Number of Participants According to Categorization of Vital Signs Data: Part 1

    Time frame: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

    Vital signs were categorized according to the following criteria for potential clinical concern: diastolic blood pressure (DBP): <50 millimeter of mercury (mmHg), increase from baseline >= 20mmHg; systolic blood pressure (SBP): <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 beats per minute (bpm), >120 bpm.

  4. Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1

    Time frame: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)

    ECG parameters were categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50 percent (%); QRS duration, aggregate (msec) >=140, percent change >= 50%; QT interval corrected by Fridericia's formula (QTcF) interval aggregate (msec): >450 to <=480, > 480 to <=500, >500, change from baseline: >30 to <=60 and change >60.

  5. Number of Participants With TEAEs: Part 2

    Time frame: Up to a maximum of 12 weeks

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  6. Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 2

    Time frame: Up to a maximum of 12 weeks

    Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (<0.8* LLN); monocytes/leukocytes (>1.2* ULN); clinical chemistry: LDL (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (>=1), urine erythrocytes (>=20), RBC casts (>1), bacteria (>20).

  7. Number of Participants According to Categorization of Vital Signs Data: Part 2

    Time frame: Up to a maximum of 12 weeks

    Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: <50 mmHg, increase from baseline >=20mmHg; systolic blood pressure: <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 bpm, >120 bpm.

  8. Number of Participants According to Categorization of ECG Data: Part 2

    Time frame: Up to a maximum of 12 weeks

    ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50%; QRS duration, aggregate (msec) >=140, percent change >=50%; QTcF interval aggregate (msec): >450 to <=480, >480 to <=500, >500, change from baseline: >30 to <=60 and change >60.

  9. Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 3

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

  10. Time for Cmax (Tmax) of PF-07202954: Part 3

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

  11. Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 3

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

  12. Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 3

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

    AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

  2. Time for Cmax (Tmax) of PF-07202954: Part 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

  3. Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

    AUClast was determined by linear/log trapezoidal method.

  4. Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

    AUCinf was determined as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate constant. Treatment groups with same dose and administration were combined as planned.

  5. Terminal Half-life (t1/2) of PF-07202954: Part 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

    T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Treatment groups with same dose and administration were combined as planned.

  6. Maximum Observed Plasma Concentration (Cmax) of PF-07202954 on Day 1, 7 and 14: Part 2

    Time frame: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

  7. Time for Cmax (Tmax) of PF-07202954 on Day 1, 7 and 14: Part 2

    Time frame: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

  8. 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

    Time frame: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

    Area under the concentration curve from time 0 to end of dosing interval (AUCtau).

  9. Terminal Half-life (t1/2) of PF-07202954 on Day 14: Part 2

    Time frame: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

  10. Amount of Unchanged Drug Recovered in Urine During Dosing Interval (Aetau) of PF-07202954 on Day 14: Part 2

    Time frame: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

    Aetau was defined as amount of unchanged drug recovered in urine during dosing interval.

  11. Percent of Dose Recovered in Urine as Unchanged Drug Over Dosing Interval (Aetau%) on Day 14: Part 2

    Time frame: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

    Aetau% was defined as percent of dose recovered in urine as unchanged drug over dosing interval.

  12. Renal Clearance (CLr) of PF-07202954 on Day 14: Part 2

    Time frame: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)

    Renal clearance was amount of unchanged drug excreted in urine over the dosing interval divided by AUCtau.

  13. Number of Participants With TEAEs: Part 3

    Time frame: Up to maximum of 6 weeks

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  14. Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 3

    Time frame: Up to maximum of 6 weeks

    Pre-defined criteria for laboratory abnormalities included, hematology: neutrophils/leukocytes (<0.8* LLN); monocytes/leukocytes (>1.2* ULN); clinical chemistry: LDL (>1.2*ULN), creatine kinase (>2.0*ULN); and urinalysis: specific gravity (<1.003); ketones, urine protein, urine hemoglobin, nitrite (>=1), urine erythrocytes (>=20), RBC casts (>1), bacteria (>20).

  15. Number of Participants According to Categorization of Vital Signs Data: Part 3

    Time frame: Up to maximum of 6 weeks

    Vital signs were planned to be categorized according to the following criteria for potential clinical concern: diastolic blood pressure: <50 mmHg, increase from baseline >=20mmHg; systolic blood pressure: <90 mmHg, increase from baseline >=30mmHg; pulse rate: <40 bpm, >120 bpm.

  16. Number of Participants According to Categorization of ECG Data: Part 3

    Time frame: Up to maximum of 6 weeks

    ECG parameters were planned to be categorized according to the following criteria for potential clinical concern: PR interval aggregate (msec) >=300, percent change >=25/50%; QRS duration, aggregate (msec) >=140, percent change >=50%; QTcF interval aggregate (msec): >450 to <=480, >480 to <=500, >500, change from baseline: >30 to <=60 and change >60.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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