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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: ABL001

• Registration Number: NCT02857868
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-27
• Study Start: 2016-05-03
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Status Verified: 2018-07
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABL001	ABL001	-

Primary Outcome Measures

Name	Time	Method
Primary Pharmacokinetics (PK): AUClast	at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose	To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Secondary Pharmacokinetics (PK): T 1/2	at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose	To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Secondary Pharmacokinetics (PK): CL/F	at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose	To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Primary Pharmacokinetics (PK): Cmax	at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose	To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Primary Pharmacokinetics (PK): AUCinf	at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose	To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Secondary Pharmacokinetics (PK): Tmax	at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose	To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Secondary Pharmacokinetics (PK): Vz/F	at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose	To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects

Secondary Outcome Measures

Name	Time	Method
ABL001 pharmacokinetic parameter - Cmax - based on unbound fraction in plasma	2 hours post-dose	Unbound fraction I plasma includes but is not limited to unbound Cmax (Cmax)
ABL001 pharmacokinetic parameter - AUClast - based on unbound fraction in plasma	2 hours post-dose	Unbound fraction I plasma includes but is not limited to unbound AUClast (AUClast)
ABL001 pharmacokinetic parameter - AUCinf - based on unbound fraction in plasma	2 hours post-dose	Unbound fraction I plasma includes but is not limited to unbound AUCinf (AUCinf)
Percentage of plasma protein binding as expressed by unbound fraction in plasma	2 hours post-dose	To evaluate ABL001 plasma protein binding

Trial Locations

Locations (3)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States

University of Miami / Clinical Research Services, Inc.; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States