Hepatic ImpairmentPhase 1NCT01433458
Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
A Phase 1 study testing RLX030A in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects. 20 to 24 patients and 20 to 24 healthy subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- RLX030A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2011to Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects:
- Female subjects must be of non-child bearing potential OR use an effective method of contraception and sexually active males must use a condom during intercourse while taking the drug and for 5 half-lives after stopping treatment
- Subjects with hepatic impairment:
- Subjects must have either mild, moderate or severe hepatic impairment
Who cannot join
- All subjects
- Hepatic impairment due to non-liver disease
- Use of other investigational drugs at time of enrollment
- History of malignancy of any organ system
- Donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to initial dosing
- Hemoglobin levels below 10.0 g/dL at screening or baseline
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- Subjects with hepatic impairment:
- Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk
- Treatment with any cytostatic drug, vasodilator, autonomic alpha blocker or B2 agonist
- Any surgical or medical condition other than hepatic impairment which might significantly alter the distribution or excretion of drugs
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Single-dose, Open-label Parallel Study to Assess the Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects
This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects.
20 to 24 patients and 20 to 24 healthy subjects will be enrolled.
- Conditions
- Hepatic Impairment
- Being tested
- RLX030A
- Keywords
- Hepatic impairment, healthy volunteers, RLX030, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLX030ADrug
RLX030 is administered as a continuous 24 hour infusion
| Study group | Role | What they receive |
|---|---|---|
| RLX030: Group 1 mild hepatic impairment | Experimental | Patients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030 Receives: Drug: RLX030A |
| RLX030: Group 2 moderate hepatic impairment | Experimental | Patients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030 Receives: Drug: RLX030A |
| RLX030: Group 3 severe hepatic impairment | Experimental | Patients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030 Receives: Drug: RLX030A |
| RLX030: Group 4 - healthy volunteers | Active comparator | Participants will receive a single IV 24 hour infusion of RLX030. This group will consist of 3 sub-groups to match patients of groups 1, 2and 3. Receives: Drug: RLX030A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time zero to infinity (AUCinf)
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Measured: Up to Day 15
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Measured: Up to Day 15
Serum concentration at 24 hour (C24h) after administration
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Measured: Upto Day 15
Secondary outcomes (6)
Number of patients with adverse events, serious adverse events and death
Monitoring of adverse events, serious adverse events and death from screening to end of study
Measured: Day 15
Determination of the presence and quantification of anti-RLX030 antibodies
Blood will be collected and serum analyzed for the presence of antiRLX030 antibodies. Anti-RLX030 antibodies will be evaluated in serum in a validated four-tiered assay approach
Measured: Day 1 (prior to administration) and Day 15 end of study
Mean residence time [MRT] of RLX030
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Measured: screening, days 1, 2, 3, 4 and 15
Terminal elimination half life (T ½) of RLX030
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Measured: screening, days 1, 2, 3, 4 and 15
Systemic clearance of RLX030 from serum (CL)
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Measured: screening, days 1, 2, 3, 4 and 15
Volume of distribution at steady state (Vss)
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Measured: screening, days 1, 2, 3, 4 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 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
- NCT01433458
- Sponsor's protocol ID
- CRLX030A2101
- Other IDs
- 2011-001596-39
- Status last verified
- Jan 2013
- First submitted
- 9 Aug 2011
- Last updated
- 21 Dec 2020
- Results posted
- No
Publications
Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45. doi: 10.1111/bcp.12572.
PubMed 25511105
Study at a glance
From the registry record, last updated by the sponsor on 21 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 RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT01433458
- Acronym / sponsor ID
- CRLX030A2101
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic impairment, healthy volunteers, RLX030, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Sep 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 RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects.
20 to 24 patients and 20 to 24 healthy subjects will be enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RLX030: Group 1 mild hepatic impairment | Experimental | Drug: RLX030APatients with mild hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
| RLX030: Group 2 moderate hepatic impairment | Experimental | Drug: RLX030APatients with moderate hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
| RLX030: Group 3 severe hepatic impairment | Experimental | Drug: RLX030APatients with severe hepatic impairment will receive a single IV 24 hour infusion of RLX030 |
| RLX030: Group 4 - healthy volunteers | Active comparator | Drug: RLX030AParticipants will receive a single IV 24 hour infusion of RLX030. This group will consist of 3 sub-groups to match patients of groups 1, 2and 3. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All subjects:
- Subjects with hepatic impairment:
Key exclusion criteria (11 listed)
- All subjects
- Subjects with hepatic impairment:
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| RLX030ARLX030 is administered as a continuous 24 hour infusion | Drug | RLX030: Group 1 mild hepatic impairment, RLX030: Group 2 moderate hepatic impairment, RLX030: Group 3 severe hepatic impairment, RLX030: Group 4 - healthy volunteers |
Primary outcome
Area under the serum concentration-time curve from time zero to infinity (AUCinf)
Time frame: Up to Day 15
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Up to Day 15
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Serum concentration at 24 hour (C24h) after administration
Time frame: Upto Day 15
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
6 secondary outcomes
Number of patients with adverse events, serious adverse events and death
Time frame: Day 15
Determination of the presence and quantification of anti-RLX030 antibodies
Time frame: Day 1 (prior to administration) and Day 15 end of study
Mean residence time [MRT] of RLX030
Time frame: screening, days 1, 2, 3, 4 and 15
Terminal elimination half life (T ½) of RLX030
Time frame: screening, days 1, 2, 3, 4 and 15
Systemic clearance of RLX030 from serum (CL)
Time frame: screening, days 1, 2, 3, 4 and 15
Volume of distribution at steady state (Vss)
Time frame: screening, days 1, 2, 3, 4 and 15
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 21 Dec 2020.
- Derived from this study: PubMed 25511105Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45. doi: 10.1111/bcp.12572.
- Results for CRLX030A2101 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RLX030A in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 2 sites in 2 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 4 inclusion and 11 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 21 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 2 sites in Germany, Russia. 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?
Area under the serum concentration-time curve from time zero to infinity (AUCinf) (time frame: Up to Day 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01433458, which also lists 1 linked publication.
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 21 Dec 2020.