Non-Alcoholic Fatty Liver DiseasePhase 1NCT04857437

Study in Healthy Adults Evaluating PF-07202954

A Phase 1 study testing PF-07202954 Repeat Dose and PF-07202954 Single Dose in people with Non-Alcoholic Fatty Liver Disease and Liver Fibrosis, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
What is being tested?: PF-07202954 Repeat Dose and PF-07202954 Single Dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 13 May 2021to 17 Sep 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

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

Conditions: Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Being tested: PF-07202954 Repeat Dose, PF-07202954 Single Dose, Placebo
Medical subject headings: Non-alcoholic Fatty Liver Disease, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-07202954 Repeat DoseDrug
10, 30, 100, 300, 600, 1200 milligrams (mg)
PF-07202954 Single DoseDrug
10, 30, 100, 300, 600, 900, 1200 milligrams (mg)
PlaceboDrug
Matching Placebo

Study groups in NCT04857437
Study group	Role	What they receive
Part 1	Experimental	Single, Escalating Doses of PF-07202954 or Placebo (Cohorts 1 and 2) Receives: Drug: PF-07202954 Single Dose; Drug: Placebo
Part 2	Experimental	Repeated, Escalating Doses of PF-07202954 or placebo from Day 1 to Day 14, inclusive (Cohorts 3, 4, 5, 6 7, and optional Cohort 8) Receives: Drug: PF-07202954 Repeat Dose; Drug: Placebo
Part 3	Experimental	Single dose of PF-07202954 with a high-fat/high-caloric meal and a single dose following an overnight fast of ≥10 hours Receives: Drug: PF-07202954 Single Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1
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.
Measured: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)
Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 1
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.
Measured: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)
Number of Participants According to Categorization of Vital Signs Data: Part 1
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.
Measured: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)
Number of Participants According to Categorization of Electrocardiogram (ECG) Data: Part 1
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.
Measured: From start of study treatment on Day 1 up to 28 days post last dose of study treatment (maximum up to 10 weeks)
Number of Participants With TEAEs: Part 2
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.
Measured: Up to a maximum of 12 weeks
Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 2
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).
Measured: Up to a maximum of 12 weeks
Number of Participants According to Categorization of Vital Signs Data: Part 2
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.
Measured: Up to a maximum of 12 weeks
Number of Participants According to Categorization of ECG Data: Part 2
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.
Measured: Up to a maximum of 12 weeks
Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 3
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Time for Cmax (Tmax) of PF-07202954: Part 3
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 3
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 3
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)

Secondary outcomes (16)

Maximum Observed Plasma Concentration (Cmax) of PF-07202954: Part 1
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Time for Cmax (Tmax) of PF-07202954: Part 1
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Area Under the Plasma Concentration Time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of PF-07202954: Part 1
AUClast was determined by linear/log trapezoidal method.
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07202954: Part 1
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.
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Terminal Half-life (t1/2) of PF-07202954: Part 1
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.
Measured: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post-dose)
Maximum Observed Plasma Concentration (Cmax) of PF-07202954 on Day 1, 7 and 14: Part 2
Measured: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
Time for Cmax (Tmax) of PF-07202954 on Day 1, 7 and 14: Part 2
Measured: 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 Plasma Concentration-time Profile From Time 0 to Time Tau (AUCtau) of PF-07202954 on Day 1, 7 and 14: Part 2
Area under the concentration curve from time 0 to end of dosing interval (AUCtau).
Measured: Day 1, 7 and 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
Terminal Half-life (t1/2) of PF-07202954 on Day 14: Part 2
Measured: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
Amount of Unchanged Drug Recovered in Urine During Dosing Interval (Aetau) of PF-07202954 on Day 14: Part 2
Aetau was defined as amount of unchanged drug recovered in urine during dosing interval.
Measured: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
Percent of Dose Recovered in Urine as Unchanged Drug Over Dosing Interval (Aetau%) on Day 14: Part 2
Aetau% was defined as percent of dose recovered in urine as unchanged drug over dosing interval.
Measured: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
Renal Clearance (CLr) of PF-07202954 on Day 14: Part 2
Renal clearance was amount of unchanged drug excreted in urine over the dosing interval divided by AUCtau.
Measured: Day 14 (pre-dose, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 14, 16 and 24 hours)
Number of Participants With TEAEs: Part 3
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.
Measured: Up to maximum of 6 weeks
Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 3
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).
Measured: Up to maximum of 6 weeks
Number of Participants According to Categorization of Vital Signs Data: Part 3
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.
Measured: Up to maximum of 6 weeks
Number of Participants According to Categorization of ECG Data: Part 3
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.
Measured: Up to maximum of 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 202117 Sep 2021

First posted23 Apr 2021
Study start13 May 2021
Primary completion17 Sep 2021
Study completion17 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04857437
Sponsor's protocol ID: C4171001
Other IDs: 2020-002121-28
Status last verified: May 2024
First submitted: 20 Apr 2021
Last updated: 20 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04857437
Acronym / sponsor ID: C4171001
Conditions: Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 13 May 2021 (actual)
Primary completion: 17 Sep 2021 (actual)
Study completion: 17 Sep 2021 (actual)
First posted: 23 Apr 2021 (actual)
Results: Posted 20 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Part 1	Experimental	Drug: PF-07202954 Single Dose, Drug: PlaceboSingle, Escalating Doses of PF-07202954 or Placebo (Cohorts 1 and 2)
Part 2	Experimental	Drug: PF-07202954 Repeat Dose, Drug: PlaceboRepeated, Escalating Doses of PF-07202954 or placebo from Day 1 to Day 14, inclusive (Cohorts 3, 4, 5, 6 7, and optional Cohort 8)
Part 3	Experimental	Drug: PF-07202954 Single DoseSingle dose of PF-07202954 with a high-fat/high-caloric meal and a single dose following an overnight fast of ≥10 hours

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-07202954 Repeat Dose10, 30, 100, 300, 600, 1200 milligrams (mg)	Drug	Part 2
PF-07202954 Single Dose10, 30, 100, 300, 600, 900, 1200 milligrams (mg)	Drug	Part 1, Part 3
PlaceboMatching Placebo	Drug	Part 1, Part 2

Primary outcome

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.
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.
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.
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.
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.
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).
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.
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.
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)
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)
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)
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).

16 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Number of Participants With TEAEs: Part 3
Time frame: Up to maximum of 6 weeks
Number of Participants With Laboratory Abnormalities Meeting Pre-defined Criteria: Part 3
Time frame: Up to maximum of 6 weeks
Number of Participants According to Categorization of Vital Signs Data: Part 3
Time frame: Up to maximum of 6 weeks
Number of Participants According to Categorization of ECG Data: Part 3
Time frame: Up to maximum of 6 weeks

Results and safety

Results posted to the registry on 20 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part1 Cohort1: Placebo/PF-07202954 100mg Std Meal/PF-07202954 600mg/PF-07202954 100mg High Fat Meal	2	2
Part1 Cohort1: PF-07202954 10mg/Placebo/PF-07202954 600mg/PF-07202954 100mg High Fat Meal	1	1
Part1 Cohort1: PF-07202954 10mg/PF-07202954 100mg Std Meal/Placebo/PF-07202954 100mg High Fat Meal	2	2
Part1 Cohort1: PF-07202954 10mg/PF-07202954 100mg Std Meal/PF-07202954 600mg/Placebo	1	1
Part1 Cohort2: Placebo/PF-07202954 300mg/PF-07202954 100mg Std Meal/PF-07202954 100mg Fasted	2	2
Part1 Cohort2: PF-07202954 30mg/Placebo/PF-07202954 100mg Std Meal/PF-07202954 100mg Fasted	1	1
Part1 Cohort2: PF-07202954 30mg/PF-07202954 300mg/Placebo/PF-07202954 100mg Fasted	1	1
Part1 Cohort2: PF-07202954 30mg/PF-07202954 300mg/PF-07202954 100mg Std Meal/Placebo	2	2

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Cohort 1 and 2: Placebo: Part 1 n = 11	Cohort 1: PF-07202954 10 mg: Part 1 n = 4	Cohort 2: PF-07202954 30 mg: Part 1 n = 4	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n = 9	Cohort 2: PF-07202954 300 mg: Part 1 n = 5	Cohort 1: PF-07202954 600 mg: Part 1 n = 4	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n = 5	Cohort 2: PF-07202954 100 mg Fasted: Part 1 n = 2
Value	3	0	1	2	1	0	1	0

Population analysed: Safety population included all participants who were randomly assigned to study treatment and who took at least 1 dose of study treatment. Treatment groups with same dose and administration were combined as planned.

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Cohort 1 and 2: Placebo: Part 1 n = 11	Cohort 1: PF-07202954 10 mg: Part 1 n = 4	Cohort 2: PF-07202954 30 mg: Part 1 n = 4	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n = 9	Cohort 2: PF-07202954 300 mg: Part 1 n = 5	Cohort 1: PF-07202954 600 mg: Part 1 n = 4	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n = 5	Cohort 2: PF-07202954 100 mg Fasted: Part 1 n = 2
Value	0	2	3	6	5	3	4	2

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Cohort 1 and 2: Placebo: Part 1 n = 11	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n = 5
DBP: <50 mmHg	1	1
DBP: Increase from baseline >=20mmHg	0	0
SBP: <90 mmHg	1	0
SBP: Increase from baseline >=30 mmHg	0	0
Pulse rate: <40 bpm	0	0
Pulse rate: >120 bpm	0	0

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Cohort 1 and 2: Placebo: Part 1 n = 11	Cohort 1: PF-07202954 10 mg: Part 1 n = 4	Cohort 2: PF-07202954 30 mg: Part 1 n = 4	Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1 n = 9	Cohort 2: PF-07202954 300 mg: Part 1 n = 5	Cohort 1: PF-07202954 600 mg: Part 1 n = 4	Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1 n = 5	Cohort 2: PF-07202954 100 mg Fasted: Part 1 n = 2
PR interval aggregate (msec): >=300	0	0	0	0	0	0	0	0
PR interval aggregate (msec): percent change >=25/50%	0	0	0	0	0	0	0	0
QRS duration, aggregate (msec): >=140	0	0	0	0	0	0	0	0
QRS duration, aggregate (msec): percent change >=50%	0	0	0	0	0	0	0	0
QTcF interval aggregate (msec): >450 to <=480	0	0	0	0	0	0	0	0
QTcF interval aggregate (msec): >480 to <=500	0	0	0	0	0	0	0	0
QTcF interval aggregate (msec): >=500	0	0	0	0	0	0	0	0
QTcF interval aggregate (msec): >30 to <=60	0	0	0	0	0	0	0	0

16 secondary outcomes are reported in the full results.

Adverse events

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) for Part 1. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 and 2: Placebo: Part 1	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Cohort 1: PF-07202954 10 mg: Part 1	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cohort 2: PF-07202954 30 mg: Part 1	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Cohort 1 and 2: PF-07202954 100 mg Standard Meal: Part 1	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Cohort 2: PF-07202954 300 mg: Part 1	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Cohort 1: PF-07202954 600 mg: Part 1	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cohort 1: PF-07202954 100 mg High Fat / High Calorie Meal: Part 1	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Cohort 2: PF-07202954 100 mg Fasted: Part 1	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07202954 Repeat Dose and PF-07202954 Single Dose in people with Non-Alcoholic Fatty Liver Disease and Liver Fibrosis, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04857437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.