NCT00692341

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2008

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

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

March 27, 2012

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

June 4, 2008

Results QC Date

February 25, 2012

Last Update Submit

April 5, 2012

Conditions

Hepatic Insufficiency

Keywords

hepatic impairment

Outcome Measures

Primary Outcomes (2)

  • 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

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

    AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

    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

Secondary Outcomes (11)

  • Area Under the Curve From Time Zero to Last Quantifiable 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

  • 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

  • Plasma Elimination Half-life (t1/2)

    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

  • Apparent Oral Clearance (CL/F)

    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

  • Apparent Volume of Distribution (Vz/F)

    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

  • +6 more secondary outcomes

Study Arms (3)

Hepatic Function - Mild Impairment

EXPERIMENTAL

Subjects with mild hepatic impairment (Child Pugh class A, score 5-6)

Drug: AG-013736

Hepatic Function - Moderate Impairment

EXPERIMENTAL

Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9)

Drug: AG-013736

Hepatic Function - Normal

EXPERIMENTAL

Group 1 1\) subjects with normal hepatic function

Drug: AG-013736

Interventions

AG-013736DRUG

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

Hepatic Function - Mild Impairment

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of reduced hepatic function (Child Pugh Classification A or B)
  • Body Mass Index of 18-32 kg/m2

You may not qualify if:

  • History of febrile illness within 5 days prior to first dose
  • Any condition possibly affecting drug absorption (e.g. gastrectomy)
  • Positive urine drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer, Inc.

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

April 11, 2012

Results First Posted

March 27, 2012

Record last verified: 2012-04

Locations

US(2)