Back to results

PF-04634817 Renal Impairment Study

Primary Purpose

Renal Insufficiency

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-04634817

About this trial

This is an interventional basic science trial for Renal Insufficiency focused on measuring Subjects with Renal Impairment, healthy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Healthy Volunteers

Mild Renal Impairment

Moderate renal impairment

Severe renal impairment

Arm Description

Outcomes

Primary Outcome Measures

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)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Maximum Observed Plasma Concentration (Cmax)

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 pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

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.

Plasma Decay Half-Life (t1/2)

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

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.

Area Under the Curve From Time Zero 48 hours[AUC (0 - 48)]

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

Secondary Outcome Measures

Urinary Ae48

Amount of drug excreted unchanged in urine over 48 hours

Urinary AE48 (% excreted)

% of drug excreted unchanged in urine over 48 hours

Urinary CLR

Full Information

NCT ID

NCT01791855

First Posted

February 12, 2013

Last Updated

October 17, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01791855

Brief Title

PF-04634817 Renal Impairment Study

Official Title

A Phase 1, Single Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04634817

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency

Keywords

Subjects with Renal Impairment, healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Volunteers

Arm Type

Experimental

Arm Title

Mild Renal Impairment

Arm Type

Experimental

Arm Title

Moderate renal impairment

Arm Type

Experimental

Arm Title

Severe renal impairment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PF-04634817

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PF-04634817

Intervention Description

Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)

Intervention Type

Drug

Intervention Name(s)

PF-04634817

Intervention Description

Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)

Intervention Type

Drug

Intervention Name(s)

PF-04634817

Intervention Description

Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame