A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
- 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.
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