A Renal Impairment Study for PF-04965842

Pfizer

Status and phase

Completed

Phase 1

Conditions

Renal Impairment

Treatments

Drug: PF-04965842

Study type

Interventional

Funder types

Industry

Identifiers

NCT03660241

2018-002865-20 (EudraCT Number)

B7451021

Details and patient eligibility

About

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).

Full description

This is a Phase 1 non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-04965842 after a single 200 mg oral dose. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted and approximately 8 subjects with moderate renal impairment will be enrolled. The total duration of participation from the Screening Visit to Day 4 will be a maximum of 31 days and from the Screening Visit to Follow-up Contact/Visit will be a maximum of 67 days.

Enrollment

23 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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).

Additional inclusion criteria for subjects with renal impairment:

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.

Exclusion criteria

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.

Additional exclusion criteria for subjects with renal impairment:

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.