PF-04634817 Renal Impairment Study
- Registration Number
- NCT01791855
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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)
- Subjects with acute renal failure
- Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
- Abnormal ECG at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate renal impairment PF-04634817 - Severe renal impairment PF-04634817 - Healthy Volunteers PF-04634817 - Mild Renal Impairment PF-04634817 -
- Primary Outcome Measures
Name Time Method Plasma Decay Half-Life (t1/2) 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 is the time measured for the plasma concentration to decrease by one half.
Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)] 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 AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.
Area Under the Curve From Time Zero to Last Quantifiable 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 plasma concentration time-curve from zero to the last measured concentration (AUClast).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] 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 AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Apparent Oral Clearance (CL/F) 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 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.
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) 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 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.
- Secondary Outcome Measures
Name Time Method Renal Clearance Over a 48-hour Interval(CLr48) 0-24, 24-48 hours post dose Renal clearance over a 48-hour interval (CLr48) = Ae48/AUC48.
Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48) 0-24, 24-48 hours post dose Amount of unchanged drug excreted in urine over 48 hours (Ae48) = urine concentration x volume of urine.
Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%) 0-24, 24-48 post dose Percentage (%) of drug excreted unchanged in urine over 48 hours (Ae48%) = Ae48/(dose x 100).
Trial Locations
- Locations (2)
Unversity of Miami
🇺🇸Miami, Florida, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States