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

NCT ID: NCT02857868

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-03

Study Completion Date

2017-07-20

Brief Summary

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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

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Conditions

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Hepatic Impairment

Keywords

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Hepatic Impairment ABL001 Child-Pugh healthy subjects with normal hepatic function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABL001

Group Type EXPERIMENTAL

ABL001

Intervention Type DRUG

Interventions

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ABL001

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of Miami / Clinical Research Services, Inc.

Miami, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

DaVita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Hoch M, Sato M, Zack J, Quinlan M, Sengupta T, Allepuz A, Aimone P, Hourcade-Potelleret F. Pharmacokinetics of Asciminib in Individuals With Hepatic or Renal Impairment. J Clin Pharmacol. 2021 Nov;61(11):1454-1465. doi: 10.1002/jcph.1926. Epub 2021 Jul 16.

Reference Type DERIVED
PMID: 34115385 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17159

Results for CABL001A2103 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CABL001A2103

Identifier Type: -

Identifier Source: org_study_id