A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function

A Phase 1, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01631097

Enrollment

Registered

2012-06-28

Start date

2012-05-31

Completion date

2014-01-31

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Brief summary

This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics, safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of hepatic impairment and normal hepatic function.

Interventions

DRUGTivozanib hydrochloride

Single oral capsule 1.5 mg tivozanib hydrochloride

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI between 18 to 38 kg/m2 * diagnosis of chronic or stable hepatic insufficiency, with a Child-Pugh classification scores of mild, moderate or severe.

Exclusion criteria

* Current or previous history of hepatic carcinoma, hepatorenal syndrome, portacaval shunt surgery, significant hepatic encephalopathy, severe ascites, or pleural effusion * Currently undergoing dialysis * Poor peripheral venous access * Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Apparent volume of distribution (Vz/F)	pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Maximum Observed Concentration (Cmax)	pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Time to maximum concentration (Tmax)	pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0 t)	pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Area under the concentration-time curve extrapolated to infinity (AUC0-∞)	pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Apparent terminal elimination rate constant (λz)	pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Apparent terminal elimination half-life (t1/2)	pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
Apparent total clearance (CL/F)	pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose

Secondary

Measure	Time frame
Change from baseline in urinalysis assessments	Baseline and End of Study Visit (Day 30)
Change from baseline in thyroid function tests	Baseline and End of Study Visit (Day 30)
Change from baseline in electrocardiograms	Baseline and End of Study Visit (Day 30)
Change from baseline in hematology including coagulation assessments	Baseline and End of Study Visit (Day 30)
Change from baseline in chemistry assessments	Baseline and End of Study Visit (Day 30)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)	up to 16 weeks
Change from baseline in vital signs	Baseline and End of Study Visit (Day 30)
Change from baseline in physical examinations	Baseline and End of Study Visit (Day 30)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026