Liver DiseasePhase 1NCT00851227
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
A Phase 1 study testing conivaptan hydrochloride in people with Liver Disease and Hyponatremia, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial summary
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Disease, Hyponatremia
- What is being tested?
- conivaptan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with Normal Hepatic Function:
- Weighs at least 45 kg
- Body mass index between 18 and 40 kg/m2 inclusive
- Must have normal hepatic function
- Hepatic Impaired Subjects:
- Weighs at least 45 kg
- Meets criteria for mild or moderate hepatic impairment defined by Child-Pugh method
- Body mass index between 18 and 40 kg/m2 inclusive
Who cannot join
- Subjects with Normal Hepatic Function:
- Smokes more than 10 cigarettes per day
- Known to be HIV positive or has HIV antibodies
- Has clinically significant history or presence of illness, malignancy, or immunodeficiency
- Is Hepatitis A, B, or C positive
- Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
Show all 16Show fewer
- History of substance abuse within 6 months prior to screening
- Hepatic Impaired Subjects:
- Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced acidities, portal hypertension, or biliary liver cirrhosis
- Is hypovolemic or has evidence of orthostatic hypotension
- Smokes more than 10 cigarettes per day
- Known to be HIV positive or has HIV antibodies
- Has clinically significant history or presence of illness, malignancy, or immunodeficiency
- Has clinically significant history or presence of GI symptoms other than those associated with moderate hepatic impairment
- Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
- History of substance abuse within 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
- Conditions
- Liver Disease, Hyponatremia
- Being tested
- conivaptan hydrochloride
- Keywords
- Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Liver Disease
- Medical subject headings
- Liver Diseases, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conivaptan hydrochlorideDrug
Also called Vaprisol, YM087
intravenous
| Study group | Role | What they receive |
|---|---|---|
| 1. Mildly Hepatic Impaired Subjects | Experimental | Not described Receives: Drug: conivaptan hydrochloride |
| 2. Moderately Hepatic Impaired Subjects | Experimental | Not described Receives: Drug: conivaptan hydrochloride |
| 3. Subjects with Normal Hepatic Function | Experimental | Not described Receives: Drug: conivaptan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure PK and protein binding of conivaptan
Measured: 5 days
Secondary outcomes (1)
Measure tolerability of conivaptan
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Art Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851227
- Sponsor's protocol ID
- 087-CL-086
- Status last verified
- Apr 2014
- First submitted
- 23 Feb 2009
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
- ClinicalTrials.gov ID
- NCT00851227
- Acronym / sponsor ID
- 087-CL-086
- Conditions
- Liver Disease, Hyponatremia
- Keywords
- Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Feb 2009 (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.
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Mildly Hepatic Impaired Subjects | Experimental | Drug: conivaptan hydrochloride |
| 2. Moderately Hepatic Impaired Subjects | Experimental | Drug: conivaptan hydrochloride |
| 3. Subjects with Normal Hepatic Function | Experimental | Drug: conivaptan hydrochloride |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with Normal Hepatic Function:
- Hepatic Impaired Subjects:
Key exclusion criteria (16 listed)
- Subjects with Normal Hepatic Function:
- Hepatic Impaired Subjects:
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 |
|---|---|---|
| conivaptan hydrochlorideAlso: Vaprisol, YM087intravenous | Drug | 1. Mildly Hepatic Impaired Subjects, 2. Moderately Hepatic Impaired Subjects, 3. Subjects with Normal Hepatic Function |
Primary outcome
Measure PK and protein binding of conivaptan
Time frame: 5 days
1 secondary outcome
Measure tolerability of conivaptan
Time frame: 5 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 2 May 2014.
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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.
Art Wheeler, MD study director
Cumberland Pharmaceuticals
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 conivaptan hydrochloride in people with Liver Disease and Hyponatremia, run by Cumberland Pharmaceuticals 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 8 inclusion and 16 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 2 May 2014. 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?
Measure PK and protein binding of conivaptan (time frame: 5 days). 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 2 May 2014.