- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02296905
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
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).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Grafton, New Zealand, 1010
- Site Reference ID/Investigator# 130590
-
-
-
-
Florida
-
Miami, Florida, United States, 33136
- Site Reference ID/Investigator# 130589
-
Orlando, Florida, United States, 32809
- Site Reference ID/Investigator# 130591
-
-
Texas
-
San Antonio, Texas, United States, 78215
- Site Reference ID/Investigator# 130588
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Evidence of liver cirrhosis OR
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I
Subjects with mild hepatic impairment
|
Up to 2 single doses of ABT-493 will be given orally in combination with 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
|
Up to 2 single doses of ABT-493 will be given orally in combination with 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
|
Up to 2 single doses of ABT-493 will be given orally in combination with 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
|
Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.
Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
7 days
|
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.
|
Up to 38 days
|
Number of subjects with adverse events
Time Frame: Up to 58 days
|
Up to 58 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: David Pugatch, MD, AbbVie
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M13-604
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatic Impairment
-
PfizerRecruitingHealthy Volunteers | Moderate Hepatic Impairment | Severe Hepatic ImpairmentUnited States
-
GlycoMimetics IncorporatedCompletedModerate Hepatic Impairment | Normal Hepatic FunctionUnited States
-
Astellas Pharma Europe B.V.Medivation, Inc.CompletedSevere Hepatic Impairment | Normal Hepatic FunctionBulgaria
-
Agios Pharmaceuticals, Inc.CompletedModerate Hepatic ImpairmentUnited States
-
Bausch Health Americas, Inc.TerminatedSevere Hepatic ImpairmentUnited States
-
Merck Sharp & Dohme LLCCompletedModerate Hepatic ImpairmentUnited States
-
EQRx International, Inc.CompletedSevere Hepatic ImpairmentUnited States
-
PfizerCompleted
-
TakedaCompletedSevere Hepatic ImpairmentUnited States
-
ShireCompleted
Clinical Trials on ABT-493
-
AbbVieCompletedRenal ImpairmentUnited States, New Zealand
-
AbbVieCompletedHepatitis C Virus (HCV)United States, Bulgaria, Canada, Czechia, France, Greece, Hungary, Ireland, Israel, Italy, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom, Vietnam
-
AbbVieApproved for marketing
-
AbbVieCompletedChronic Hepatitis C Virus (HCV) Infection
-
AbbVieCompleted
-
AbbVieCompletedChronic Hepatitis C Virus (HCV) Infection
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C Virus | HCV | Direct-Acting Antiviral Agent (DAA)-Experienced
-
AbbVieCompletedHepatitis C Virus Infection | Chronic Hepatitis C | Human Immunodeficiency Virus Infection | Compensated Cirrhosis and Non-cirrhotics
-
AbbVieCompletedA Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 InfectionChronic Hepatitis C | Hepatitis C Virus | HCV