Study in Healthy Adults Evaluating PF-07202954

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04857437
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease; Liver Fibrosis	Drug: PF-07202954 Repeat Dose; Drug: PF-07202954 Single Dose; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: May 13, 2021
• Actual Primary Completion Date: Sep 17, 2021
• Actual Study Completion Date: Sep 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 Single, Escalating Doses of PF-07202954 or Placebo (Cohorts 1 and 2)	Drug: PF-07202954 Single Dose; 10, 30, 100, 300, 600, 900, 1200 milligrams (mg); Drug: Placebo; Matching Placebo
Experimental: Part 2 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)	Drug: PF-07202954 Repeat Dose; 10, 30, 100, 300, 600, 1200 milligrams (mg); Drug: Placebo; Matching Placebo
Experimental: Part 3 Single dose of PF-07202954 with a high-fat/high-caloric meal and a single dose following an overnight fast of ≥10 hours	Drug: PF-07202954 Single Dose; 10, 30, 100, 300, 600, 900, 1200 milligrams (mg)

Outcome Measures

Primary Outcome Measures

1. Number of Subjects reporting treatment emergent adverse events (AEs) [Baseline through follow up Day 30]

   Part 1 and Part 2

2. Incidence of treatment emergent clinical laboratory abnormalities [Baseline through follow up Day 30]

   Part 1 and Part 2

3. Incidence of treatment emergent vital signs [Baseline through follow up Day 30]

   Part 1 and Part 2

4. Incidence of treatment emergent Electrocardiogram (ECG) abnormalities [Baseline through follow up Day 30]

   Part 1 and Part 2

5. Maximum plasma concentration (C[max]) [0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4]

   Part 3 (if conducted)

6. Time to Reach Maximum Observed Plasma Concentration (Tmax) [0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4]

   Part 3 (if conducted)

7. Area under the plasma concentration time AUC[last]) [0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4]

   Part 3 (if conducted)

8. Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf) [0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4]

   Part 3 (if conducted)

Secondary Outcome Measures

1. Cmax [Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4. Part 2 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14]

   Part 1 and Part 2

2. Tmax [Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4. Part 2 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14]

   Part 1 and Part 2

3. AUClast [Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4.]

   Part 1

4. AUCinf [Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4.]

   Part 1

5. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [Part 2 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14]

   Part 2

6. Time measured for plasma concentration to decrease by one half (Terminal half-life) [t(1/2)]. [Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4. Part 2 (Repeat Dose) - Day 14]

   Part 1 and Part 2

7. Amount of unchanged drug recovered in urine during dosing interval (AE[tau]) [Day 14]

   Part 2

8. Percent of dose recovered in urine as unchanged drug over dosing interval (AE[tau%]) [Day 14]

   Part 2

9. Renal Clearance (CLr) [Day 14]

   Part 2

10. AEs [Baseline through follow up Day 30]

    Part 3 (if conducted)

11. Incidence of treatment emergent clinical laboratory abnormalities [Baseline through follow up Day 30]

    Part 3 (if conducted)

12. Incidence of treatment emergent vital signs [Baseline through follow up Day 30]

    Part 3 (if conducted)

13. ECG abnormalities [Baseline through follow up Day 30]

    Part 3 (if conducted)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04857437
• Other Study ID Numbers: C4171001; 2020-002121-28
• First Posted: Apr 23, 2021
• Last Update Posted: Nov 15, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Study Results

No Results Posted as of Nov 15, 2021