Hepatic ImpairmentPhase 1NCT01456663
A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects
A Phase 1 study testing AFQ056 in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 3 sites in 3 countries.
Trial summary
This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects. 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?
- AFQ056
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2011to Jul 2012
- 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
- Groups 1, 2, 3 and 4 (all subjects)
- Male and female Caucasian subjects
- Group 1, 2 and 3 (subjects with hepatic impairment)
- Subjects must satisfy the criteria for hepatic impairment as evidenced by a Child-Pugh score of A, B or C at screening
- Group 4 (healthy subjects)
- Each healthy subject must match in age (±8 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1, 2 or 3.
Who cannot join
- Groups 1, 2, 3 and 4 (all subjects)
- Use of any tobacco products from 1 week prior to cotinine screening assessments until study completion.
- Group 1, 2 and 3 (subjects with hepatic impairment)
- History of drug or alcohol abuse within 3 months prior to screening
- History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition.
- Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
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- History or presence of encephalopathy within 6 months prior screening (except for subjects in Groups 2 and 3).
- Documented presence of a porto-systemic shunt.
- Documented presence of esophagus varices (stage III or IV).
- Group 4 (healthy subjects)
- History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline.
- History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Single-dose, Open-label, Parallel Study to Assess the Pharmacokinetics of AFQ056 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects
This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
- Conditions
- Hepatic Impairment
- Being tested
- AFQ056
- Keywords
- AFQ056, Hepatic impairment, Hepatic impaired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFQ056Drug
| Study group | Role | What they receive |
|---|---|---|
| AFQ056 | Experimental | Not described Receives: Drug: AFQ056 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups
AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose
Secondary outcomes (2)
Measure: : Number of subjects with adverse event in each group
Number and type of adverse events, number and type of findings in standard laboratory results, special laboratory results (Hypothaliamic-pituitary axis, porphyrin profile) electrocardiogram holters, or in vital signs
Measured: From dose administration (day 1) to 13+/- 2 days after the single dose administration
Measure: Plasma protein binding results of AFQ056 in each groups.
Measured: 2 hours after single dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2012
- Study completionJul 2012
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 Novartis PharmaceuticalsThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456663
- Sponsor's protocol ID
- CAFQ056A2123
- Other IDs
- 2011-000748-28
- Status last verified
- Feb 2013
- First submitted
- 24 Aug 2011
- Last updated
- 8 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label, Parallel Study to Assess the Pharmacokinetics of AFQ056 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT01456663
- Acronym / sponsor ID
- CAFQ056A2123
- Conditions
- Hepatic Impairment
- Keywords
- AFQ056, Hepatic impairment, Hepatic impaired
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Oct 2011 (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 study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFQ056 | Experimental | Drug: AFQ056 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Groups 1, 2, 3 and 4 (all subjects)
- Male and female Caucasian subjects
- Group 1, 2 and 3 (subjects with hepatic impairment)
- Subjects must satisfy the criteria for hepatic impairment as evidenced by a Child-Pugh score of A, B or C at screening
- Group 4 (healthy subjects)
Key exclusion criteria (14 listed)
- Groups 1, 2, 3 and 4 (all subjects)
- Use of any tobacco products from 1 week prior to cotinine screening assessments until study completion.
- Group 1, 2 and 3 (subjects with hepatic impairment)
- History of drug or alcohol abuse within 3 months prior to screening
- History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition.
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 |
|---|---|---|
| AFQ056 | Drug | AFQ056 |
Primary outcome
Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose
AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F
2 secondary outcomes
Measure: : Number of subjects with adverse event in each group
Time frame: From dose administration (day 1) to 13+/- 2 days after the single dose administration
Measure: Plasma protein binding results of AFQ056 in each groups.
Time frame: 2 hours after single dose administration
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 8 Dec 2020.
- Results for CAFQ056A2123 can be found on the Novartis Clinical Trial Results websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFQ056 in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 3 sites in 3 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 6 inclusion and 14 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany, Hungary. 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?
Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups (time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose). 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 8 Dec 2020.