Phase 1
N=24
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
Hepatic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00692341 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) — 30.43; 26.96; 38.85 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AG-013736 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
30.43; 26.96; 38.85 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
155.68; 121.96; 303.96 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
148.43; 115.98; 295.23 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
3.50; 2.75; 4.00 | — |
| SECONDARY Plasma Elimination Half-life (t1/2) |
4.74; 3.61; 7.12 | — |
| SECONDARY Apparent Oral Clearance (CL/F) |
535.3; 683.3; 274.2 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
166.43; 162.65; 127.68 | — |
| SECONDARY Fraction of Unbound Drug (fu) |
0.004; 0.003; 0.004 | — |
| SECONDARY Unbound Apparent Oral Clearance (CLu/F) |
132218.6; 120883.5; 67143.1 | — |
| SECONDARY Unbound Apparent Volume of Distribution (Vzu/F) |
41108.6; 42378.3; 31268.8 | — |
| SECONDARY Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u] |
0.63; 0.69; 1.24 | — |
| SECONDARY Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) |
0.60; 0.67; 1.21 | — |
| SECONDARY Unbound Maximum Observed Plasma Concentration (Cmaxu) |
0.12; 0.13; 0.16 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00692341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.