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

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ClinicalTrials.gov Identifier: NCT02296905
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie

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).


Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: ABT-493 Drug: ABT-530 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
Study Start Date : October 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Group I
Subjects with mild hepatic impairment
Drug: ABT-493
Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

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

Experimental: Group II
Subjects with moderate hepatic impairment
Drug: ABT-493
Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

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

Experimental: Group III
Subjects with severe hepatic impairment
Drug: ABT-493
Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

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

Experimental: Group IV
Subjects with normal hepatic function
Drug: ABT-493
Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.

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




Primary Outcome Measures :
  1. Overall measurement of pharmacokinetic parameter values of ABT-493 and ABT-530 [ Time Frame: 7 days ]
    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).

  2. Overall measurement of safety parameters [ Time Frame: Up to 38 days ]
    Measurement of safety parameters include physical examinations, clinical laboratory tests, 12-lead ECGs (electrocardiograms) and vital signs.

  3. Number of subjects with adverse events [ Time Frame: Up to 58 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: All Subjects

  • 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

In addition to the inclusion criteria above for all subjects, the following criteria must be met for subjects with normal hepatic function enrolled in Group IV:

  • 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

In addition to the inclusion criteria for all subjects, the following criteria must be met for all subjects with hepatic impairment enrolled in Groups I, II and III:

  • 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: - History of significant sensitivity to any drug.

  • 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.

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): NCT02296905


Locations
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United States, Florida
Site Reference ID/Investigator# 130589
Miami, Florida, United States, 33136
Site Reference ID/Investigator# 130591
Orlando, Florida, United States, 32809
United States, Texas
Site Reference ID/Investigator# 130588
San Antonio, Texas, United States, 78215
New Zealand
Site Reference ID/Investigator# 130590
Grafton, New Zealand, 1010
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: David Pugatch, MD AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02296905     History of Changes
Other Study ID Numbers: M13-604
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by AbbVie:
Hepatic Impairment
Hepatitis C Virus Infection

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases