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

• Status: Completed
• Trial end date: 2017-07-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.