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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02296905




Registration number
NCT02296905
Ethics application status
Date submitted
19/11/2014
Date registered
21/11/2014
Date last updated
21/10/2015

Titles & IDs
Public title
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
Scientific title
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
Secondary ID [1] 0 0
M13-604
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatic Impairment 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-493
Treatment: Drugs - ABT-530

Experimental: Group I - Subjects with mild hepatic impairment

Experimental: Group II - Subjects with moderate hepatic impairment

Experimental: Group III - Subjects with severe hepatic impairment

Experimental: Group IV - Subjects with normal hepatic function


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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Overall measurement of safety parameters - Measurement of safety parameters include physical examinations, clinical laboratory tests, 12-lead ECGs (electrocardiograms) and vital signs.
Timepoint [2] 0 0
Up to 38 days
Primary outcome [3] 0 0
Number of subjects with adverse events
Timepoint [3] 0 0
Up to 58 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
New Zealand
State/province [3] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02296905
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Pugatch, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications