Renal Impairment Study of PF-06700841

NCT04260464 | Completed Phase 1 Results FDA Drug

• 1 other identifier: B7931048
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy Volunteer; Renal Impairment

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• 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

  Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

• 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

  AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data.

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

• Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

  Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

• AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

  AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data.

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

Secondary Outcomes (4)

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

  From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)

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

  Baseline (Day -1) and Day 4

• Number of Participants With Post-baseline Vital Sign Abnormalities

  Baseline (Day 1) and Day 4

• Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities

  0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4

Study Arms (4)

PF-06700841 Severe Renal Impairment

EXPERIMENTAL

This arm includes participants with severe renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Drug: PF-06700841

PF-06700841 Normal Renal Function

EXPERIMENTAL

This arm includes participants with normal renal function who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Drug: PF-06700841

PF-06700841 Moderate Renal Impairment

EXPERIMENTAL

This arm includes participants with moderate renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Drug: PF-06700841

PF-06700841 Mild Renal Impairment

EXPERIMENTAL

This arm includes participants with mild renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Drug: PF-06700841

Interventions

PF-06700841 DRUG

A single dose of 30 mg PF-06700841 will be administered on Day 1

PF-06700841 Mild Renal Impairment; PF-06700841 Moderate Renal Impairment; PF-06700841 Normal Renal Function; PF-06700841 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:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

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

Miami, Florida, 33136, United States

Location

University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency

Interventions

PF-06700841

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: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: July 3, 2020
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: January 22, 2024
• Results First Posted: January 22, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)