Study in Healthy Adults Evaluating PF-07202954

Non-Alcoholic Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857437
• Other study ID #: C4171001
• Secondary ID: 2020-002121-28
• Status: Completed
• Phase: Phase 1
• Start date: May 13, 2021
• Est. completion date: September 17, 2021

Study information

• Verified date: November 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 17, 2021
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatty Liver
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• PF-07202954 Repeat Dose
10, 30, 100, 300, 600, 1200 milligrams (mg)
• PF-07202954 Single Dose
10, 30, 100, 300, 600, 900, 1200 milligrams (mg)
• Placebo
Matching Placebo

Locations

Country	Name	City	State
United States	New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects reporting treatment emergent adverse events (AEs)	Part 1 and Part 2	Baseline through follow up Day 30
Primary	Incidence of treatment emergent clinical laboratory abnormalities	Part 1 and Part 2	Baseline through follow up Day 30
Primary	Incidence of treatment emergent vital signs	Part 1 and Part 2	Baseline through follow up Day 30
Primary	Incidence of treatment emergent Electrocardiogram (ECG) abnormalities	Part 1 and Part 2	Baseline through follow up Day 30
Primary	Maximum plasma concentration (C[max])	Part 3 (if conducted)	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
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)	Part 3 (if conducted)	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
Primary	Area under the plasma concentration time AUC[last])	Part 3 (if conducted)	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
Primary	Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)	Part 3 (if conducted)	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
Secondary	Cmax	Part 1 and Part 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 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14
Secondary	Tmax	Part 1 and Part 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 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14
Secondary	AUClast	Part 1	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.
Secondary	AUCinf	Part 1	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.
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Part 2	Part 2 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14
Secondary	Time measured for plasma concentration to decrease by one half (Terminal half-life) [t(1/2)].	Part 1 and Part 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
Secondary	Amount of unchanged drug recovered in urine during dosing interval (AE[tau])	Part 2	Day 14
Secondary	Percent of dose recovered in urine as unchanged drug over dosing interval (AE[tau%])	Part 2	Day 14
Secondary	Renal Clearance (CLr)	Part 2	Day 14
Secondary	AEs	Part 3 (if conducted)	Baseline through follow up Day 30
Secondary	Incidence of treatment emergent clinical laboratory abnormalities	Part 3 (if conducted)	Baseline through follow up Day 30
Secondary	Incidence of treatment emergent vital signs	Part 3 (if conducted)	Baseline through follow up Day 30
Secondary	ECG abnormalities	Part 3 (if conducted)	Baseline through follow up Day 30

External Links

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