NCT01791855

Brief Summary

Patients with renal impairment are the target population for PF-04634817. The clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. This study will investigate the effect of the drug in subjects with varying degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 10, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2013

Completed
10.5 years until next milestone

Results Posted

Study results publicly available

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

February 12, 2013

Results QC Date

May 12, 2022

Last Update Submit

August 3, 2023

Conditions

Renal Insufficiency

Keywords

Subjects with Renal Impairmenthealthy

Outcome Measures

Primary Outcomes (8)

  • Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)]

    AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.

    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]

    AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.

    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

  • Apparent Oral Clearance (CL/F)

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

  • Maximum Observed Plasma Concentration (Cmax)

    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

  • Apparent Volume of Distribution (Vz/F)

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

  • Plasma Decay Half-Life (t1/2)

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

Secondary Outcomes (3)

  • Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48)

    0-24, 24-48 hours post dose

  • Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%)

    0-24, 24-48 post dose

  • Renal Clearance Over a 48-hour Interval(CLr48)

    0-24, 24-48 hours post dose

Study Arms (4)

Healthy Volunteers

EXPERIMENTAL
Drug: PF-04634817

Mild Renal Impairment

EXPERIMENTAL
Drug: PF-04634817

Moderate renal impairment

EXPERIMENTAL
Drug: PF-04634817

Severe renal impairment

EXPERIMENTAL
Drug: PF-04634817

Interventions

PF-04634817DRUG

Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)

Healthy Volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female (non child bearing potential aged 18-75 years
  • Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

You may not qualify if:

  • Subjects with acute renal failure
  • Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
  • Abnormal ECG at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Unversity of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Tesch GH, Pullen N, Jesson MI, Schlerman FJ, Nikolic-Paterson DJ. Combined inhibition of CCR2 and ACE provides added protection against progression of diabetic nephropathy in Nos3-deficient mice. Am J Physiol Renal Physiol. 2019 Dec 1;317(6):F1439-F1449. doi: 10.1152/ajprenal.00340.2019. Epub 2019 Sep 30.

    PMID: 31566438DERIVED

Related Links

MeSH Terms

Conditions

Renal Insufficiency

Interventions

PF-04634817

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Limitations and Caveats

Designation of primary and secondary endpoints was based on the discretion of the study team, as the endpoints were not characterized clearly in the study protocol.

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
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 15, 2013

Study Start

May 10, 2013

Primary Completion

September 3, 2013

Study Completion

September 3, 2013

Last Updated

March 1, 2024

Results First Posted

March 1, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

US(2)