Clinical trial NCT04260464: Renal Impairment Study of PF-06700841
Official title: A PHASE 1, NON-RANDOMIZED, OPEN LABEL, SINGLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-06700841 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Renal Impairment
Keywords: Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-02-07
Enrollment: 30
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
Intervention model description: Single group
Primary purpose: OTHER

Brief summary: The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.

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-06700841 after a single oral dose of 30 mg. 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 4 will be a maximum of 32 days and from Screening visit to Follow-up/Contact Visit will a maximum of 67 days.

Eligibility criteria: Inclusion Criteria:

* Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit.
* Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight \>50 kg.
* Normal, Severe, Moderate and Mild renal function at 2 Screening visits.
* Stable drug regimen

Exclusion Criteria:

* 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 to first dose
* Known history of pulmonary embolism or recurrent deep vein thrombosis
* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
timeFrame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
timeFrame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
measure: Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
timeFrame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
measure: AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
timeFrame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
measure: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
timeFrame: Baseline (Day -1) and Day 4
measure: Number of Participants With Post-baseline Vital Sign Abnormalities
timeFrame: Baseline (Day 1) and Day 4
measure: Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities
timeFrame: 0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy
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 Research LLC dba Nucleus Network
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: