Liver DiseasePhase 1NCT01370148
A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
A Phase 1 study testing conivaptan hydrochloride in people with Liver Disease, run by Cumberland Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Disease
- 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
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2011to Feb 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with Normal Hepatic Function:
- Female subject must be either:
- post-menopausal prior to Screening, or
- premenarchal prior to Screening, or
- documented surgically sterile or post hysterectomy, or
- if of childbearing potential, must have a negative pregnancy test at Screening and must be using highly effective contraception prior to Screening and throughout the study period and for 28 days after final study drug administration
Show all 29Show fewer
- Female subject must not be lactating and must not be breastfeeding at Screening or during the study period, and for 28 days after final study drug administration
- Female subject must not donate ova starting at Screening or during the study period, and for 28 days after final study drug administration
- Male subject must:
- be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 28 days after final study drug administration
- not donate sperm starting at Screening and throughout the study period, and for at least 28 days after final study drug administration
- Subject weighs at least 45 kg and has a body mass index between 18 and 40 kg/m2 inclusive
- The subject must have clinical laboratory test results within normal range, including liver function tests (LFTs)
- The subject must have had a normal 12-lead electrocardiogram (ECG)
- Hepatic Impaired Subjects:
- Female subject must be either:
- post-menopausal prior to Screening, or
- premenarchal prior to Screening, or
- documented surgically sterile or post hysterectomy, or
- if of childbearing potential, must have a negative pregnancy test at Screening and must be using highly effective contraception prior to Screening and throughout the study period and for 28 days after final study drug administration
- Female subject must not be lactating and must not be breastfeeding at Screening or during the study period, and for 28 days after final study drug administration
- Female subject must not donate ova starting at Screening or during the study period, and for 28 days after final study drug administration
- Male subject must:
- be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 28 days after final study drug administration
- not donate sperm starting at Screening and throughout the study period, and for at least 28 days after final study drug administration
- Subject meets criteria for severe hepatic impairment defined by Child-Pugh method
- Subject weighs at least 45 kg and has a body mass index between 18 and 40 kg/m2 inclusive
- The subject must have clinical laboratory test results within therapeutic range except for hepatic disease
- The subject must have had a normal 12-lead electrocardiogram (ECG)
Who cannot join
- Subjects with Normal Hepatic Function:
- Subject has a history of a clinically significant illness, and associated clinical symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study
- Subject has evidence of biliary obstruction or other causes of hepatic impairment
- Subject is known to have hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is known to be HIV positive or has HIV antibodies
- Subject has an impaired ability to sense thirst
- Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L
Show all 31Show fewer
- Subject has either a systolic blood pressure (BP) of greater than 140 mmHg or a diastolic BP of less than 56 mmHg
- Subject has taken any prescription or over-the-counter medications except for contraceptives, hormone replacement therapy and occasional acetaminophen, or alternative and complementary medicines within past 14 days
- Subject has a history of carcinoma, except for basal cell or cutaneous squamous cell carcinoma within past 5 years
- Subject drinks greater than 14 units of alcohol per week (Note: one unit = 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits)
- Subject has a history of substance abuse within past 6 months prior to Screening Visit or the subject tests positive at Screening or clinic admission for alcohol or drugs of abuse
- Subject is currently participating in another clinical trial or has received an investigational medication within past 30 days
- Subject is known to have hypersensitivity to conivaptan or its derivatives
- Subject has had a blood transfusion or donated/lost more than 550ml of blood within past 8 weeks
- Subject is incapable of being compliant with the protocol
- Subjects with Hepatic Impairment:
- Subject has a history of a clinically significant illness, and associated clinical symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study. Subjects with controlled hypertension may be allowed
- Subject has a condition associated with hepatic disease including; biliary obstruction, or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver, fluctuating or rapidly deteriorating hepatic function, biliary liver cirrhosis, history or presence of hepatic encephalopathy greater than Grade 1 within past 3 months or unstable encephalopathy prior to Screening, tense ascites, esophageal/gastric variceal bleeding with past 6 months, server portal hypertension, surgical portal systemic shunt or peritoneal venous shunt, thrombocyte level below 50,000 x 10^9/L and prothrombin time (PT) above 18 seconds
- Subject is hypovolemic or has evidence of orthostatic hypotension
- Subject has an impaired ability to sense thirst
- Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L
- Subject has either a systolic blood pressure (BP) of greater than 140 mmHg or a diastolic BP of less than 56 mmHg
- Subject is known to be HIV positive or has HIV antibodies
- Subject has had a change in dose regimen of medication needed for their underlying medical condition with the past four weeks
- Subject is currently taking a prohibited medication
- Subject drinks greater than 14 units of alcohol per week (Note: one unit equals 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits)
- Subject has a history of substance abuse within past 6 months prior to Screening Visit or the subject tests positive at Screening or clinic admission for alcohol or drugs of abuse
- Subject is currently participating in another clinical trial or has received an investigational medication with past 30 days
- Subject has had a blood transfusion or donated/lost more than 550ml of blood within past 8 weeks
- Subject is known to have hypersensitivity of conivaptan or its derivatives
- Subject is incapable of being compliant with the protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
DaVita Clinical Research
Lakewood, Colorado, 80228
Orlando Clinical Research
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.
Read the detailed description
Subjects will be admitted to the Phase 1 unit Day -2 and will remain confined to the unit until discharge on Study Day 5 after completion of all study procedures.
- Conditions
- Liver Disease
- Being tested
- conivaptan hydrochloride
- Keywords
- Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Liver Disease, YM087
- Medical subject headings
- Liver Diseases
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 |
|---|---|---|
| Subjects with severe hepatic impairment | Experimental | Not described Receives: Drug: conivaptan hydrochloride |
| Subjects with normal hepatic function | Active comparator | Not described Receives: Drug: conivaptan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of severe hepatic impairment on the plasma drug concentration of conivaptan through analysis of blood samples
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 posted9 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionFeb 2014
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
- 17 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
- NCT01370148
- Sponsor's protocol ID
- 087-CL-099
- Status last verified
- Apr 2014
- First submitted
- 8 Jun 2011
- 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 Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
- ClinicalTrials.gov ID
- NCT01370148
- Acronym / sponsor ID
- 087-CL-099
- Conditions
- Liver Disease
- Keywords
- Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Liver Disease, YM087
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Jun 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.
The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.
Detailed description
Subjects will be admitted to the Phase 1 unit Day -2 and will remain confined to the unit until discharge on Study Day 5 after completion of all study procedures.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with severe hepatic impairment | Experimental | Drug: conivaptan hydrochloride |
| Subjects with normal hepatic function | Active comparator | Drug: conivaptan hydrochloride |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- post-menopausal prior to Screening, or
- premenarchal prior to Screening, or
- documented surgically sterile or post hysterectomy, or
- if of childbearing potential, must have a negative pregnancy test at Screening and must be using highly effective contraception prior to Screening and throughout the study period and for 28 days after final study drug administration
- be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 28 days after final study drug administration
Key exclusion criteria (31 listed)
- Subject has a history of a clinically significant illness, and associated clinical symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study
- Subject has evidence of biliary obstruction or other causes of hepatic impairment
- Subject is known to have hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is known to be HIV positive or has HIV antibodies
- Subject has an impaired ability to sense thirst
- Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L
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 | Subjects with normal hepatic function, Subjects with severe hepatic impairment |
Primary outcome
Assess the effect of severe hepatic impairment on the plasma drug concentration of conivaptan through analysis of blood samples
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.
Related trials for Liver Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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
3 sites 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, run by Cumberland Pharmaceuticals at 3 sites 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 29 inclusion and 31 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 3 sites 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?
Assess the effect of severe hepatic impairment on the plasma drug concentration of conivaptan through analysis of blood samples (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.