A Hepatic Impairment Study for PF-04965842.

NCT03626415 | Completed Phase 1 Results FDA Drug

• 1 other identifier: B7451020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1 non randomized, open label, single dose, parallel cohort study to investigate the effect of hepatic impairment on the PK, safety and tolerability of PF 04965842.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) for PF-04965842

  Cmax is maximum plasma concentration. It was observed directly from data.

  0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72 hours post-dose in each cohort

• Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) for PF-04965842

  AUCinf is area under the concentration-time curve (AUC) from time 0 (pre-dose) extrapolated to infinite time.

  0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72 hours post-dose in each cohort

Secondary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) for PF-04965842

  From screening (within 28 days prior to Day 1) till up to 36 days post-dose, the total maximum duration was approximately 63 days for individual participants.

• Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

  Screening (within 28 days prior to Day 1), Day -1, 2, 24, 72 hours post-dose.

• Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance for PF-04965842

  Screening (within 28 days prior to Day 1), Day -1, 2, 72 hours post-dose.

• Number of Participants With Vital Sign Findings of Potential Clinical Importance for PF-04965842

  Screening (within 28 days prior to Day 1), 0 (pre-dose), and 72 hours post-dose.

Study Arms (1)

PF-04965842

EXPERIMENTAL

PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.

Drug: PF-04965842

Interventions

PF-04965842 DRUG

PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.

PF-04965842

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 pounds).
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild: Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points), within 14 days of investigational product administration.
• A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or magnetic resonance imaging (MRI).

You may not qualify if:

• Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days, history of disseminated herpes simplex infection or recurrent (\>1 episode) or disseminated herpes zoster.
• Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as less than 1 year).
• Subjects who have previously had a transplanted kidney, liver, or heart.
• At Screening, persistent severe, uncontrolled hypertension.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Prism Clinical Research, LLC

Saint Paul, Minnesota, 55114, United States

Location

Related Publications (2)

• Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.

  PMID: 35061234 DERIVED

• Wang EQ, Le V, O'Gorman M, Tripathy S, Dowty ME, Wang L, Malhotra BK. Effects of Hepatic Impairment on the Pharmacokinetics of Abrocitinib and Its Metabolites. J Clin Pharmacol. 2021 Oct;61(10):1311-1323. doi: 10.1002/jcph.1858. Epub 2021 Apr 17.

  PMID: 33749838 DERIVED

Related Links

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

MeSH Terms

Interventions

abrocitinib

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Recruitment for subjects with moderate and mild hepatic impairment (Cohorts 1 and 2) will initiate first and these subjects will be enrolled in parallel.

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: October 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 18, 2020
• Results First Posted: May 18, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)