A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects

Novartis Pharmaceuticals32 enrolled

Overview

The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Impairment

Interventions

ABL001DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion criteria: * Body mass index of 18-36 kg/m2, with body weight 50 kg and no more than 120 kg * Vital signs (after at least 3 minutes rest in the supine position) within the following ranges (inclusive): * Oral body temperature between 35.0 °C - 37.5 °C (95.0-99.5°F) * Systolic BP ≥90 mmHg and ≤140 mmHg * Diastolic BP ≥60 mmHg and ≤90 mmHg for healthy subjects and 50-100 mmHg for subjects with impaired hepatic function (groups 2-4) * Pulse Rate: ≥50 and ≤90 bpm for healthy subjects (group 1) and ≥50 and ≤100 bpm for subjects with impaired hepatic function (groups 2-4) * Healthy subjects with no clinically significant abnormalities as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory test * Subjects with Child-Pugh Clinical Assessment Score as calculated per the Child-Pugh classification Key Exclusion Criteria: * Presence of clinically significant ECG abnormalities or a family history or presence of prolonged QT-interval syndrome * History of cardiac disease * Sexually active males must use a condom during intercourse while taking the drug and for 7 days after stopping * Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs * Administration of strong or moderate CYP3A4 inhibitors or inducers (including St John's wort) within 14 days prior to dosing Other protocol-defined inclusion/exclusion criteria may apply.

Locations (3)

University of Miami / Clinical Research Services, Inc.

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

DaVita Clinical Research

Minneapolis, Minnesota, United States