Kidney Failure, ChronicPhase 1NCT01975337
Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects
A Phase 1 study testing Alisporivir in people with Kidney Failure, Chronic, run by Debiopharm International SA at 1 site in United States.
Trial summary
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Alisporivir
- 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
- Aug 2013to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provides written informed consent before any assessment is performed
- Matched healthy participants are in good health as determined by past medical history, physical examination, vital signs, laboratory tests, and other assessments
- ESRD participants are on a protocol-defined stable hemodialysis regimen and have no evidence of hepatic decompensation, with vital signs and other tests within protocol-specified limits
- Weighs at least 50 kg
- Is able to communicate well with the investigator, to understand and comply with the requirements of the study.
Who cannot join
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff;
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- the analysis of results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of Alisporivir (DEB025) in Subjects With End Stage Renal Disease on Hemodialysis Compared to Matched Healthy Subjects
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir when administered to subjects with ESRD.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Alisporivir
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlisporivirDrug
Also called DEB025
Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack)
| Study group | Role | What they receive |
|---|---|---|
| End stage renal disease participants | Experimental | End stage renal disease (ESRD) participants received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food at any time during the 2 hours after completion of hemodialysis on Day 1. Receives: Drug: Alisporivir |
| Matched healthy participants | Active comparator | Healthy participants (matched to those with end stage renal disease by sex, age, weight, and smoking status), received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food on Day 1. Receives: Drug: Alisporivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed maximum plasma concentration of alisporivir following drug administration [mass / volume] (Cmax)
Measured: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Area under the plasma concentration-time curve for alisporivir from time zero to time 'infinity' [mass x time / volume] (AUCinf)
Measured: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Area under the plasma concentration-time curve for alisporivir from time zero to the time of the last quantifiable concentration [mass x time / volume] (AUClast)
Measured: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Secondary outcomes (4)
Time to reach peak or maximum concentration of alisporivir following drug administration [time] (Tmax)
Measured: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
The terminal elimination half-life [time] (T1/2) for alisporivir
Measured: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Apparent systemic (or total body) clearance from plasma following extravascular administration of alisporivir [volume / time] (CL/F)
Measured: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
The apparent volume of distribution during the terminal elimination phase following extravascular administration of alisporivir [volume] (Vz/F)
Measured: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startAug 2013
- 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 Kidney Failure, ChronicStudies 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
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975337
- Sponsor's protocol ID
- CDEB025A2112
- Status last verified
- Aug 2016
- First submitted
- 7 Oct 2013
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of Alisporivir (DEB025) in Subjects With End Stage Renal Disease on Hemodialysis Compared to Matched Healthy Subjects
- ClinicalTrials.gov ID
- NCT01975337
- Acronym / sponsor ID
- CDEB025A2112
- Conditions
- Kidney Failure, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Nov 2013 (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 primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir when administered to subjects with ESRD.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End stage renal disease participants | Experimental | Drug: AlisporivirEnd stage renal disease (ESRD) participants received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food at any time during the 2 hours after completion of hemodialysis on Day 1. |
| Matched healthy participants | Active comparator | Drug: AlisporivirHealthy participants (matched to those with end stage renal disease by sex, age, weight, and smoking status), received a single 400 mg (2 x 200 mg capsules) oral dose of alisporivir with food on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provides written informed consent before any assessment is performed
- Matched healthy participants are in good health as determined by past medical history, physical examination, vital signs, laboratory tests, and other assessments
- ESRD participants are on a protocol-defined stable hemodialysis regimen and have no evidence of hepatic decompensation, with vital signs and other tests within protocol-specified limits
- Weighs at least 50 kg
- Is able to communicate well with the investigator, to understand and comply with the requirements of the study.
Key exclusion criteria (5 listed)
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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 |
|---|---|---|
| AlisporivirAlso: DEB025Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack) | Drug | End stage renal disease participants, Matched healthy participants |
Primary outcome
Observed maximum plasma concentration of alisporivir following drug administration [mass / volume] (Cmax)
Time frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Area under the plasma concentration-time curve for alisporivir from time zero to time 'infinity' [mass x time / volume] (AUCinf)
Time frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Area under the plasma concentration-time curve for alisporivir from time zero to the time of the last quantifiable concentration [mass x time / volume] (AUClast)
Time frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
4 secondary outcomes
Time to reach peak or maximum concentration of alisporivir following drug administration [time] (Tmax)
Time frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
The terminal elimination half-life [time] (T1/2) for alisporivir
Time frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
Apparent systemic (or total body) clearance from plasma following extravascular administration of alisporivir [volume / time] (CL/F)
Time frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
The apparent volume of distribution during the terminal elimination phase following extravascular administration of alisporivir [volume] (Vz/F)
Time frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose
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 17 Aug 2016.
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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
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 Alisporivir in people with Kidney Failure, Chronic, run by Debiopharm International SA 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 5 inclusion and 5 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 17 Aug 2016. 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?
Observed maximum plasma concentration of alisporivir following drug administration [mass / volume] (Cmax) (time frame: Pre-dose (0 hours) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 65 hours post-dose). 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?
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 17 Aug 2016.