A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers

NCT04016077 | Completed Phase 1 Results FDA Drug

• 1 other identifier: B7981016
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this study.

Conditions

Hepatic Impairment; Healthy Participants

Keywords

PF-06651600; Pharmacokinetics; Hepatic impairment

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600

  AUC24 of PF-06651600 pre and post dose.

  Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10

• Maximum Plasma Concentration (Cmax) for PF-06651600

  Cmax is maximum observed plasma concentration.

  Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10

Secondary Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related)

  Baseline (Day 0) up to 28 days after last dose of study medication (Day 39)

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

  Baseline (Day 0) up to 28 days after last dose of study medication (Day 39)

• Number of Participants With Out of Range Vital Signs

  Baseline (Day 0) up to 28 days after last dose of study medication (Day 39)

• Number of Adverse Events Leading to Discontinuation

  Baseline (Day 0) up to 28 days after last dose of study medication (Day 39)

Study Arms (3)

PF-06651600 Moderate Hepatic Impairment

EXPERIMENTAL

This arm includes participants with moderate hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.

Drug: PF-06651600 30 mg

PF-06651600 Healthy participants

EXPERIMENTAL

This arm includes healthy adult participants who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.

Drug: PF-06651600 30 mg

PF-06651600 Mild Hepatic Impairment

EXPERIMENTAL

This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met. The arm includes participants with mild hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.

Drug: PF-06651600 30 mg

Interventions

PF-06651600 30 mg DRUG

PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.

PF-06651600 Healthy participants; PF-06651600 Mild Hepatic Impairment; PF-06651600 Moderate Hepatic Impairment

Eligibility Criteria

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

You may qualify if:

• Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures
• Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lb)
• Healthy male or female participants
• No known or suspected hepatic disease
• Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days prior to the Screening visit
• No other ongoing clinically significant abnormalities based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests except for the abnormal findings that are related to the participant's hepatic impairment.
• Satisfy the criteria for Class A or Class B of the Child-Pugh classification (mild: Child-Pugh Scores 5-6 points, and moderate: Child Pugh Scores 7-9 points), within 28 days of investigational product administration.

You may not qualify if:

• Has active acute or chronic infection requiring treatment or history of systemic infection requiring hospitalization, incl. herpes zoster, herpes simplex, tuberculosis
• Infection with hepatitis B, hepatitis C or HIV
• Any condition affecting drug absorption, distribution, metabolism and excretion (eg, status post porta-caval shunt surgery, prior bariatric surgery, gastrectomy, ileal resection)
• Has malignancy, lymphoproliferative disorder, surgery or other condition not allowed per protocol
• \- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease
• \- Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score \>9 or medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded per protocol

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Publications (2)

• Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.

  PMID: 37917289 DERIVED

• Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.

  PMID: 36977960 DERIVED

Related Links

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

MeSH Terms

Interventions

PF-06651600

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
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: July 19, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)