Clinical trial NCT04037865: A Renal Impairment Study for PF-06651600
Official title: A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-07-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Detailed description: This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06651600 after multiple oral doses of 50 mg daily. 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 approximately 16 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 with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 11 will be a maximum of 39 days and from Screening visit to Follow-up/Contact Visit will a maximum of 73 days.

Eligibility criteria: Inclusion Criteria:

* 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 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

Exclusion Criteria:

* 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

Additional exclusion criteria for subjects with renal impairment:

* Subjects requiring hemodialysis and peritoneal dialysis
* Screening BP \>/=180 mmHg (systolic) or \>/=110 mmHg (diastolic)
* Screening 12-lead ECG demonstrating QTcF \>470 msec

Primary outcomes:
measure: Plasma PF-06651600 Maximum Plasma Concentration (Cmax)
timeFrame: 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.
measure: Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
timeFrame: 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:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From Screening (Day -28) through and including up to 35 calendar days after the last administration of investigational product, assessed up to 74 days.
measure: Number of Participants With Laboratory Abnormalities
timeFrame: At Screening Visit 1 and on Days -1, 5, 11 and early termination day.
measure: Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
timeFrame: At screening, on Day 1, Day 5, Day 11 and early termination/discontinuation.
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
timeFrame: At screening, on Day -1, Day 11 and early termination/discontinuation.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigational Drug Services (IDS) University of Miami Hospitals and Clinics
state: Florida
city: Miami
country: United States
facility: University of Miami Division of Clinical Pharmacology
state: Florida
city: Saint Paul
country: United States
facility: Prism Clinical Research, LLC
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: