Hepatic ImpairmentPhase 1NCT02296905
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
A Phase 1 study testing ABT-493 and ABT-530 in people with Hepatic Impairment, run by AbbVie at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- ABT-493 and ABT-530
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2014to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Site Reference ID/Investigator# 130589
Miami, Florida, 33136
Site Reference ID/Investigator# 130591
Orlando, Florida, 32809
Site Reference ID/Investigator# 130588
San Antonio, Texas, 78215
About this study
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
- Being tested
- ABT-493, ABT-530
- Keywords
- Hepatic Impairment, Hepatitis C Virus Infection
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-493Drug
Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.
ABT-530Drug
Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Subjects with mild hepatic impairment Receives: Drug: ABT-493; Drug: ABT-530 |
| Group II | Experimental | Subjects with moderate hepatic impairment Receives: Drug: ABT-493; Drug: ABT-530 |
| Group III | Experimental | Subjects with severe hepatic impairment Receives: Drug: ABT-493; Drug: ABT-530 |
| Group IV | Experimental | Subjects with normal hepatic function Receives: Drug: ABT-493; Drug: ABT-530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days
Overall measurement of safety parameters
Measurement of safety parameters include physical examinations, clinical laboratory tests, 12-lead ECGs (electrocardiograms) and vital signs.
Measured: Up to 38 days
Number of subjects with adverse events
Measured: Up to 58 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Pugatch, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296905
- Sponsor's protocol ID
- M13-604
- Status last verified
- Oct 2015
- First submitted
- 19 Nov 2014
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT02296905
- Acronym / sponsor ID
- M13-604
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment, Hepatitis C Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: ABT-493, Drug: ABT-530Subjects with mild hepatic impairment |
| Group II | Experimental | Drug: ABT-493, Drug: ABT-530Subjects with moderate hepatic impairment |
| Group III | Experimental | Drug: ABT-493, Drug: ABT-530Subjects with severe hepatic impairment |
| Group IV | Experimental | Drug: ABT-493, Drug: ABT-530Subjects with normal hepatic function |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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:
- 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):
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-493Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530. | Drug | Group I, Group II, Group III, Group IV |
| ABT-530Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493. | Drug | Group I, Group II, Group III, Group IV |
Primary outcome
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).
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.
Number of subjects with adverse events
Time frame: Up to 58 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pugatch, MD study director
AbbVie
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-493 and ABT-530 in people with Hepatic Impairment, run by AbbVie at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall measurement of pharmacokinetic parameter values of ABT-493 and ABT-530 (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.