PF-04634817 Renal Impairment Study

Renal Insufficiency Clinical Trial

Official title:

A PHASE 1, SINGLE DOSE, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS OF PF-04634817

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791855
• Other study ID #: B1261008
• Secondary ID: 2013-000360-29
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2013
• Est. completion date: September 3, 2013

Study information

• Verified date: August 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 3, 2013
• Est. primary completion date: September 3, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• PF-04634817
Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)
• PF-04634817
Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)
• PF-04634817
Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)
• PF-04634817
Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Locations

Country	Name	City	State
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Unversity of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48)	Amount of unchanged drug excreted in urine over 48 hours (Ae48) = urine concentration x volume of urine.	0-24, 24-48 hours post dose
Secondary	Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%)	Percentage (%) of drug excreted unchanged in urine over 48 hours (Ae48%) = Ae48/(dose x 100).	0-24, 24-48 post dose
Secondary	Renal Clearance Over a 48-hour Interval(CLr48)	Renal clearance over a 48-hour interval (CLr48) = Ae48/AUC48.	0-24, 24-48 hours post dose

External Links

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