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

NCT02296905 | Completed Phase 1

• 1 other identifier: M13-604
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 4

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

Keywords

Hepatic Impairment; Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (3)

• Overall measurement of pharmacokinetic parameter values of ABT-493 and ABT-530

  Pharmacokinetic parameter values include the maximum plasma concentration (Cmax), the terminal phase elimination rate constant (B), the area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).

  7 days

• Overall measurement of safety parameters

  Measurement of safety parameters include physical examinations, clinical laboratory tests, 12-lead ECGs (electrocardiograms) and vital signs.

  Up to 38 days

• Number of subjects with adverse events

  Up to 58 days

Study Arms (4)

Group I

EXPERIMENTAL

Subjects with mild hepatic impairment

Drug: ABT-493; Drug: ABT-530

Group II

EXPERIMENTAL

Subjects with moderate hepatic impairment

Drug: ABT-493; Drug: ABT-530

Group III

EXPERIMENTAL

Subjects with severe hepatic impairment

Drug: ABT-493; Drug: ABT-530

Group IV

EXPERIMENTAL

Subjects with normal hepatic function

Drug: ABT-493; Drug: ABT-530

Interventions

ABT-493 DRUG

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

Group I; Group II; Group III; Group IV

ABT-530 DRUG

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

Group I; Group II; Group III; Group IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Site Reference ID/Investigator# 130589

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 130591

Orlando, Florida, 32809, United States

Location

Site Reference ID/Investigator# 130588

San Antonio, Texas, 78215, United States

Location

Site Reference ID/Investigator# 130590

Grafton, 1010, New Zealand

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

glecaprevir; pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• David Pugatch, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (3); NZ (1)