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NCT00692341 Clinical Trial

Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics

Hepatic Insufficiency Clinical Trial

Official title:
A Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Subjects With Impaired Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00692341
Other study ID # A4061036
Secondary ID
Status Completed
Phase Phase 1
First received June 4, 2008
Last updated April 5, 2012
Start date May 2008
Est. completion date October 2008

Study information
Verified date April 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of reduced hepatic function (Child Pugh Classification A or B)

- Body Mass Index of 18-32 kg/m2

Exclusion Criteria:

- History of febrile illness within 5 days prior to first dose

- Any condition possibly affecting drug absorption (e.g. gastrectomy)

- Positive urine drug screen

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AG-013736
Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
• AG-013736
Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
• AG-013736
Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Locations
Country Name City State
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Observed Plasma Concentration (Cmax) 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hours (hrs) post-dose No
Primary Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] AUC (0 - 8) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary 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). 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary Plasma Elimination Half-life (t1/2) Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half. 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary 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 oral bioavailability. 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. 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary 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 oral bioavailability. 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary Fraction of Unbound Drug (fu) Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration. 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary Unbound Apparent Oral Clearance (CLu/F) Clearance of an unbound drug is a measure of the rate at which an unbound drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Unbound drug clearance is a quantitative measure of the rate at which an unbound drug substance is removed from the blood. 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary Unbound Apparent Volume of Distribution (Vzu/F) Volume of distribution of unbound drug is defined as the theoretical volume in which the total amount of unbound drug would need to be uniformly distributed to produce the desired plasma concentration of unbound drug. Unbound apparent volume of distribution after oral dose (Vzu/F) is influenced by the oral bioavailability. 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)u] AUC (0 - 8)u = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) for unbound drug. It is obtained from AUCu (0 - t) plus AUCu (t - 8). 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug. 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
Secondary Unbound Maximum Observed Plasma Concentration (Cmaxu) Cmaxu is the highest measured unbound plasma concentration during the dosing interval. 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose No
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