A Renal Impairment Study for PF-06651600

NCT04037865 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: B7981020
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment (Part 2).

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (2)

• Plasma PF-06651600 Maximum Plasma Concentration (Cmax)

  The plasma PF-06651600 Cmax was observed directly from data.

  On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.

• Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)

  Plasma PF-06651600 AUC0-24 was determined using a linear/log trapezoidal method.

  On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.

Secondary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  From Screening (Day -28) through and including up to 35 calendar days after the last administration of investigational product, assessed up to 74 days.

• Number of Participants With Laboratory Abnormalities

  At Screening Visit 1 and on Days -1, 5, 11 and early termination day.

• Number of Participants With Vital Signs Data Meeting Pre-specified Criteria

  At screening, on Day 1, Day 5, Day 11 and early termination/discontinuation.

• Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria

  At screening, on Day -1, Day 11 and early termination/discontinuation.

Study Arms (4)

PF-06651600 Severe Renal Impairment

EXPERIMENTAL

This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10

Drug: PF-06651600

PF-06651600 Normal Renal Function

EXPERIMENTAL

This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10

Drug: PF-06651600

PF-06651600 Moderate Renal Impairment

EXPERIMENTAL

This arm is in Part 2 which will be conducted if decision criterion to proceed to Part 2 is met. This arm includes participants with moderate renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10

Drug: PF-06651600

PF-06651600 Mild Renal 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 renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10.

Drug: PF-06651600

Interventions

PF-06651600 DRUG

PF-06651600 50 mg oral tablets will be administered on Days 1 to 10

PF-06651600 Mild Renal Impairment; PF-06651600 Moderate Renal Impairment; PF-06651600 Normal Renal Function; PF-06651600 Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 75 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 \</= 40.0 kg/m2; and a total body weight \> 50 kg (110 lb)
• Meet the following eGFR criteria during the screening period based upon MDRD equation:
• Severe renal impairment: eGFR \<30 mL/min but not requiring hemodialysis
• Moderate renal impairment (Part 2 only): eGFR \>/=30 mL/min and \<60 mL/min
• Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min
• Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included)
• Stable drug regimen

You may not qualify if:

• Females of child-bearing potential must use an accepted, highly effective contraceptive method
• Renal transplant recipients
• Urinary incontinence without catheterization
• Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or disseminated herpes zoster
• Subjects with malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of skin or cervical carcinoma in situ
• HIV, Hepatitis B, or Hepatitis C infection
• Subjects requiring hemodialysis and peritoneal dialysis
• Screening BP \>/=180 mmHg (systolic) or \>/=110 mmHg (diastolic)
• Screening 12-lead ECG demonstrating QTcF \>470 msec

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Investigational Drug Services (IDS) University of Miami Hospitals and Clinics

Miami, Florida, 33136, United States

Location

University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Prism Clinical Research, LLC

Saint Paul, Minnesota, 55114, 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

Conditions

Renal Insufficiency

Interventions

PF-06651600

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Since the study was terminated, the results of this study was not complete and the interpretation of the study results was limited.

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

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 26, 2019
• First Posted: July 30, 2019
• Study Start: August 19, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)