Hepatic ImpairmentPhase 1NCT01126086
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment
A Phase 1 study testing otamixaban XRP0673 in people with Hepatic Impairment, run by Sanofi at 3 sites in United States.
Trial summary
Primary Objective: To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban. Secondary Objective: To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- otamixaban XRP0673
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Apr 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with hepatic impairment:
- Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive
- Stable chronic liver disease assessed by medical history, physical examination, laboratory values
- Vital signs, cardiac function and laboratory parameters within the acceptable range for subjects with hepatic impairment
- If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal
- Patients with hepatic impairment will be matched to healthy subjects who are defined as healthy by physical examination, medical history and laboratory findings and are matched to patients with respect to age, gender, and body weight. Inclusion/exclusion criteria for healthy subjects may differ slightly from those listed for patients and are defined in the study protocol
Who cannot join
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness
- Creatinine level above the upper limit of normal
- Hepatocarcinoma
- Acute hepatitis
- Hepatic encephalopathy grade 2, 3 and 4
- History or presence of drug or alcohol abuse within two years before inclusion
Show all 9Show fewer
- Smoking more than 15 cigarettes or equivalent per day, unable to refrain from smoking during the institutionalization
- Any significant change in chronic treatment medication within 14 days before inclusion
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Investigational Site Number 840002
Knoxville, Tennessee, 37920
Investigational Site Number 840003
Miami Gardens, Florida, 33169
Investigational Site Number 840001
Orlando, Florida, 32809
About this study
Official title: An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 μg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function.
Primary Objective:
- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban.
Secondary Objective:
- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.
Read the detailed description
The duration of each part of the study for one subject was 28 days of screening, 1 day of treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after start of infusion.
- Conditions
- Hepatic Impairment
- Being tested
- otamixaban XRP0673
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otamixaban XRP0673Drug
Pharmaceutical form: solution for injection
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Mild impairment | Experimental | Patients with mild hepatic impairment Receives: Drug: otamixaban XRP0673 |
| Moderate impairment | Experimental | Patients with moderate impairment Receives: Drug: otamixaban XRP0673 |
| Healthy subjects | Experimental | Matched healthy subjects Receives: Drug: otamixaban XRP0673 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z
Measured: Day 1 to Day 4
Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR)
Measured: Screening (-28 days) up to 4 days after treatment
Secondary outcomes (1)
Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG
Measured: Screening (-28 days) up 8 to 11 days after treament
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
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 SanofiThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126086
- Sponsor's protocol ID
- POP6207
- Other IDs
- U1111-1116-8891
- Status last verified
- May 2014
- First submitted
- 17 May 2010
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 μg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function.
- ClinicalTrials.gov ID
- NCT01126086
- Acronym / sponsor ID
- POP6207
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 May 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.
Primary Objective:
- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban.
Secondary Objective:
- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.
Detailed description
The duration of each part of the study for one subject was 28 days of screening, 1 day of treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after start of infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild impairment | Experimental | Drug: otamixaban XRP0673Patients with mild hepatic impairment |
| Moderate impairment | Experimental | Drug: otamixaban XRP0673Patients with moderate impairment |
| Healthy subjects | Experimental | Drug: otamixaban XRP0673Matched healthy subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with hepatic impairment:
- Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive
- Stable chronic liver disease assessed by medical history, physical examination, laboratory values
- Vital signs, cardiac function and laboratory parameters within the acceptable range for subjects with hepatic impairment
- If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal
Key exclusion criteria (9 listed)
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness
- Creatinine level above the upper limit of normal
- Hepatocarcinoma
- Acute hepatitis
- Hepatic encephalopathy grade 2, 3 and 4
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 |
|---|---|---|
| otamixaban XRP0673Pharmaceutical form: solution for injection Route of administration: intravenous | Drug | Healthy subjects, Mild impairment, Moderate impairment |
Primary outcome
PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z
Time frame: Day 1 to Day 4
Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR)
Time frame: Screening (-28 days) up to 4 days after treatment
1 secondary outcome
Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG
Time frame: Screening (-28 days) up 8 to 11 days after treament
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 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.
Clinical Sciences & Operations study director
Sanofi
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 otamixaban XRP0673 in people with Hepatic Impairment, run by Sanofi 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 6 inclusion and 9 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 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?
PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z (time frame: Day 1 to Day 4). The study lists 2 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 8 May 2014.