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

Novartis

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: ABL001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02857868

CABL001A2103

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

ABL001

Experimental group

Treatment:

Drug: ABL001