A Renal Impairment Study for PF-04965842

NCT03660241 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: B74510212018-002865-20
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 4

Brief Summary

This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with moderate renal impairment (Part 2).

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (6)

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

  Maximum observed plasma PF-04965842 concentration.

  0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

• Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-04965842

  Area under the plasma PF-04965842 concentration-time profile from time 0 extrapolated to infinite time.

  0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.

• Maximum Observed Plasma Concentration (Cmax) for PF-06471658 (M1)

  Maximum observed plasma concentration for active metabolite, PF-06471658 (M1).

  0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.

• Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06471658 (M1)

  Area under the plasma concentration-time profile from time 0 extrapolated to infinite time for active metabolite, PF-06471658 (M1).

  0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.

• Maximum Observed Plasma Concentration (Cmax) for PF-07055087 (M2)

  Maximum observed plasma concentration for active metabolite, PF-07055087 (M2).

  0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.

• Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07055087 (M2)

  Area under the plasma concentration-time profile from time 0 extrapolated to infinite time for active metabolite, PF-07055087 (M2).

  0 (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose.

Secondary Outcomes (4)

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

  Baseline up to Follow-Up (Day 36)

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

  Baseline, post-dose on Day 1, Day 2 and Day 4.

• Number of Participants With Clinically Significant Vital Sign Values

  Day 1 (pre-dose) and Day 4

• Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values

  Baseline, post-dose on Day 1 and on Day 4

Study Arms (1)

PF-04965842

EXPERIMENTAL

PF 04965842 is an oral selevtive janus kinase (JAK) 1 inhibitor

Drug: PF-04965842

Interventions

PF-04965842 DRUG

PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).

PF-04965842

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breath alcohol test at Screening and Day -1 must be negative.
• 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 on the 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.
• Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
• Stable concomitant drug regimen.

You may not qualify if:

• Renal transplant recipients.
• Urinary incontinence without catheterization.
• 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 prior to baseline, history of disseminated herpes simplex infection or recurrent 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.
• History of or current positive results for human immunodeficiency virus, Hepatitis B, Hepatitis C.
• Subjects requiring hemodialysis and peritoneal dialysis.
• Screening BP ≥ 180 mm Hg (systolic) or ≥ 110 mm Hg (diastolic).
• Screening supine 12-lead ECG demonstrating QTcF \>470 msec or a QRS interval \>120 msec.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Brussels Clinical Research Unit

Brussels, Be-bru, B-1070, Belgium

Location

Related Publications (1)

• Wang EQ, Le V, Winton JA, Tripathy S, Raje S, Wang L, Dowty ME, Malhotra BK. Effects of Renal Impairment on the Pharmacokinetics of Abrocitinib and Its Metabolites. J Clin Pharmacol. 2022 Apr;62(4):505-519. doi: 10.1002/jcph.1980. Epub 2022 Feb 15.

  PMID: 34637151 DERIVED

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

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

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

Model Details: Part 1 will be conducted. The 8 subjects from the renal impaired group will be recruited before recruiting the 8 subjects without renal impairment function in Part 1. After statistical evaluation of results from Part 1, Part 2 may be conducted.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: October 5, 2018
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: March 22, 2022
• Results First Posted: December 17, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); BE (1)