Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function

NCT ID: NCT02296905

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-09-30

Brief Summary

This is an open-label, single-dose study designed to assess the pharmacokinetics and safety of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to those in subjects with normal hepatic function.

Twenty-four subjects will be selected and enrolled according to the subject selection criteria: 6 subjects with mild stable chronic hepatic impairment (Group I), 6 subjects with moderate stable chronic hepatic impairment (Group II), 6 subjects with severe stable chronic hepatic impairment (Group III) and 6 subjects with normal hepatic function (Group IV).

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group I

Subjects with mild hepatic impairment

Group Type: EXPERIMENTAL

ABT-493

Intervention Type: DRUG

Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type: DRUG

Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.

Group II

Subjects with moderate hepatic impairment

Group Type: EXPERIMENTAL

ABT-493

Intervention Type: DRUG

Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type: DRUG

Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.

Group III

Subjects with severe hepatic impairment

Group Type: EXPERIMENTAL

ABT-493

Intervention Type: DRUG

Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type: DRUG

Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.

Group IV

Subjects with normal hepatic function

Group Type: EXPERIMENTAL

ABT-493

Intervention Type: DRUG

Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type: DRUG

Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.

Interventions

ABT-493

Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

Intervention Type: DRUG

ABT-530

Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• If female, subject must be either postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
• Females must have negative results for pregnancy test performed:

• At Screening on a urine specimen obtained within 28 days prior to initial study drug administration, and
• On a serum sample obtained on Study Day -1 of Period 1.
• Males must be surgically sterile or practicing at least one of the following methods of birth control (sperm donation within the study period is not allowed):

• Abstinence
• Partner(s) using an Intrauterine Device (IUD)
• Partner(s) using oral, injected, or implanted methods of hormonal contraceptives
• Subject and/or partner(s) using double-barrier method.

Subjects with Normal Hepatic Function

• Judged to be in general good health based upon the results of a medical history, physical examination, laboratory profile (including liver function parameters within the limits of normal) and 12-lead electrocardiogram (ECG).
• Negative hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results.
• Body Mass Index (BMI) is ≥ 18 to < 38 kg/m2, inclusive.

Subjects with Hepatic Impairment

• Judged to be in stable condition and acceptable for study participation based upon the results of a medical history, physical examination, laboratory profile and ECG.
• BMI is ≥ 18 to < 38 kg/m2, inclusive, for subjects with hepatic impairment without ascites or subjects with subclinical ascites detected only by ultrasound or other imaging. For subjects with hepatic impairment and clinically significant ascites, BMI is permitted in the range between ≥ 18 to < 40 kg/m2, inclusive.
• Child-Pugh classification of Categories A (mild), B (moderate), or C (severe).
• Medical history of chronic liver disease including and not limited to chronic hepatitis B, history of alcoholic liver disease and chronic hepatitis C.
• Presence of clinically significant hepatic impairment as indicated by either:

1. Evidence of liver cirrhosis OR

2. Medical history of at least one of the following criteria:

• Clinical diagnosis of liver disease
• Total bilirubin, > 2 mg/dl, with indirect/direct ratio < 1 or prolonged prothrombin time elevation > 1.7 or an albumin value below the lower limit of the laboratory reference range and excluding non-hepatic causes of the previous laboratory abnormalities.

Exclusion Criteria

• Pregnant or breastfeeding female.
• Recent (6-month) history of drug or alcohol abuse.
• Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM) or human immunodeficiency virus antibody (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.
• Detectable HCV RNA.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Pugatch, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 130589

Miami, Florida, United States

Site Reference ID/Investigator# 130591

Orlando, Florida, United States

Site Reference ID/Investigator# 130588

San Antonio, Texas, United States

Site Reference ID/Investigator# 130590

Grafton, , New Zealand

Countries

United States; New Zealand

Other Identifiers

M13-604

Identifier Type: -

Identifier Source: org_study_id