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

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ClinicalTrials.gov Identifier: NCT02857868
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: ABL001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Multi-center, Single-dose Study to Evaluate the Pharmacokinetics of ABL001 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function
Actual Study Start Date : May 3, 2016
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : July 20, 2017

Arm Intervention/treatment
Experimental: ABL001 Drug: ABL001



Primary Outcome Measures :
  1. Primary Pharmacokinetics (PK): Cmax [ Time Frame: 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

  2. Primary Pharmacokinetics (PK): AUClast [ Time Frame: 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

  3. Primary Pharmacokinetics (PK): AUCinf [ Time Frame: 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

  4. Secondary Pharmacokinetics (PK): Tmax [ Time Frame: 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

  5. Secondary Pharmacokinetics (PK): T 1/2 [ Time Frame: 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

  6. Secondary Pharmacokinetics (PK): CL/F [ Time Frame: 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

  7. Secondary Pharmacokinetics (PK): Vz/F [ Time Frame: 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 :
  1. Percentage of plasma protein binding as expressed by unbound fraction in plasma [ Time Frame: 2 hours post-dose ]
    To evaluate ABL001 plasma protein binding

  2. ABL001 pharmacokinetic parameter - Cmax - based on unbound fraction in plasma [ Time Frame: 2 hours post-dose ]
    Unbound fraction I plasma includes but is not limited to unbound Cmax (Cmax)

  3. ABL001 pharmacokinetic parameter - AUClast - based on unbound fraction in plasma [ Time Frame: 2 hours post-dose ]
    Unbound fraction I plasma includes but is not limited to unbound AUClast (AUClast)

  4. ABL001 pharmacokinetic parameter - AUCinf - based on unbound fraction in plasma [ Time Frame: 2 hours post-dose ]
    Unbound fraction I plasma includes but is not limited to unbound AUCinf (AUCinf)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857868


Locations
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United States, Florida
University of Miami / Clinical Research Services, Inc.
Miami, Florida, United States, 33136
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02857868    
Other Study ID Numbers: CABL001A2103
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hepatic Impairment
ABL001
Child-Pugh
healthy subjects with normal hepatic function
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases