Liver DiseasePhase 1NCT01187186
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
A Phase 1 study testing ASP1941 in people with Liver Disease, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the Child-Pugh Classification (CPC). Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Disease
- What is being tested?
- ASP1941
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2010
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with Moderate Hepatic Impairment
- Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating
- Weights at least 45 kg
- Body mass index between 18 and 34 kg/m2
- Meets criteria for moderate hepatic impairment defined by Child-Pugh method
- Subjects with Normal Hepatic Function
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- Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating
- Weights at least 45 kg
- Body mass index between 18 and 34 kg/m2
- Must have normal hepatic function defined by Child-Pugh method
Who cannot join
- Subjects with Moderate Hepatic Impairment
- Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal /gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation.
- Has severe or moderate renal dysfunction
- Known to be human immunodeficiency virus (HIV) positive
- Has clinically significant history or presence of illness, malignancy or immunodeficiency
- Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in
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- Has history of alcoholism or drug/chemical/substance abuse within past 2 years
- Subjects with Normal Hepatic Function
- Has severe or moderate renal dysfunction
- Known to be human immunodeficiency virus (HIV) positive
- Has clinically significant history or presence of illness, malignancy or immunodeficiency
- Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in
- Has history of alcoholism or drug/chemical/substance abuse within past 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the Child-Pugh Classification (CPC).
Read the detailed description
Study drug will be orally administered on Day 1. Subjects will be admitted to the clinic until completion of clinic discharge procedures on Day 7 with an outpatient follow-up visit 6-9 days after clinic discharge.
- Conditions
- Liver Disease
- Being tested
- ASP1941
- Keywords
- Liver disease, ASP1941
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1941Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Subjects with Moderate Hepatic Impairment Receives: Drug: ASP1941 |
| Normal Hepatic Function | Experimental | Subjects with Normal Hepatic Function Receives: Drug: ASP1941 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples
Measured: 7 days following study drug administration
Secondary outcomes (1)
Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples
Measured: 7 days following study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187186
- Sponsor's protocol ID
- 1941-CL-0063
- Status last verified
- Oct 2010
- First submitted
- 20 Aug 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
- ClinicalTrials.gov ID
- NCT01187186
- Acronym / sponsor ID
- 1941-CL-0063
- Conditions
- Liver Disease
- Keywords
- Liver disease, ASP1941
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Aug 2010 (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.
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the Child-Pugh Classification (CPC).
Detailed description
Study drug will be orally administered on Day 1. Subjects will be admitted to the clinic until completion of clinic discharge procedures on Day 7 with an outpatient follow-up visit 6-9 days after clinic discharge.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Hepatic Impairment | Experimental | Drug: ASP1941Subjects with Moderate Hepatic Impairment |
| Normal Hepatic Function | Experimental | Drug: ASP1941Subjects with Normal Hepatic Function |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with Moderate Hepatic Impairment
- Subjects with Normal Hepatic Function
Key exclusion criteria (13 listed)
- Subjects with Moderate Hepatic Impairment
- Subjects with Normal Hepatic Function
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 |
|---|---|---|
| ASP1941oral | Drug | Moderate Hepatic Impairment, Normal Hepatic Function |
Primary outcome
Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples
Time frame: 7 days following study drug administration
1 secondary outcome
Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples
Time frame: 7 days following study drug 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 7 Oct 2010.
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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.
Use Central Contact study director
Astellas Pharma Global Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP1941 in people with Liver Disease, run by Astellas Pharma Inc at 1 site in United States.
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 10 inclusion and 13 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 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples (time frame: 7 days following study drug administration). 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 7 Oct 2010.