Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency

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Novartis

Status and phase

Completed
Phase 1

Conditions

Hepatic Insufficiency

Treatments

Drug: Everolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00968591
CRAD001X2102
EudraCT 2009-012295-27

Details and patient eligibility

About

This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.

Enrollment

34 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All subjects:

In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values (except for values related to hepatic insufficiency).

Hepatic impaired subjects:

  • A Child-Pugh Classification score clinically determined as Class A, Class B, or Class C.
  • Absolute neutrophil count (ANC) > 1000 cells/mm3
  • Hemoglobin > 9 mg/mL
  • Platelet count > 50,000/mm3 at screening and baseline
  • Serum creatinine ≤ 2.0 x ULN
  • Free of significant medical disorders unrelated to the subject's hepatic disorder

Exclusion criteria

All subjects:

  • Significant illness, including infections, or hospitalization within 4 weeks prior to dosing (hospitalization is allowed for hepatic impaired subjects if related to liver disease). Invasive systemic fungal infections need to be fully resolved prior to study entry.
  • History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
  • History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug (everolimus) or drugs similar to the study drug (other mTOR inhibitors, e.g., rapamycin or temsirolimus).
  • Active bleeding during the last 28 days prior to dosing, including variceal bleeding.
  • Except for hepatic impairment, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study.
  • Use of tobacco within 7 days prior to dosing or during the study.
  • Consumption of alcohol within 3 days prior to dosing or during the study.
  • Consumption of grapefruits, grapefruit juice, Sevilla oranges, starfruit or related foods within 7 days prior to dosing or during the study period.
  • Use of any drugs known to affect CYP3A4 or PgP, including both inhibitors and inducers, within 7 days prior to dosing or during the study.

Hepatic impaired subjects:

Symptoms or history of Grade 3 or 4 hepatic encephalopathy within 4 weeks of study entry.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

RAD001
Experimental group
Treatment:
Drug: Everolimus

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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