Renal ImpairmentPhase 1NCT00984113
Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
A Phase 1 study testing Elinogrel in people with Renal Impairment, run by Portola Pharmaceuticals at 2 sites in United States.
Trial summary
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Elinogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Dec 2009
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and sign the written informed consent
- Subjects should have either normal renal function or have stable renal disease
Who cannot join
- History of heart disease
- Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NOCR-Knoxville
Knoxville, Tennessee, 37920
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of Elinogrel and Its Metabolite in Patients With Mild, Moderate, and Severe Renal Impairment Compared to Healthy Subjects
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.
Read the detailed description
Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects.
- mild renal impairment: CrCl from 50 to ≤80 ml/min
- moderate renal impairment: CrCl from 30 to <50 ml/min
- severe renal impairment: CrCl of <30 ml/min
- Conditions
- Renal Impairment
- Being tested
- Elinogrel
- Keywords
- Elinogrel, Renal impairment, Healthy, Kidney dysfunction
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElinogrelDrug
Also called PRT060128
100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)
| Study group | Role | What they receive |
|---|---|---|
| A-Patients with mild renal impairment | Experimental | Not described Receives: Drug: Elinogrel |
| B-Healthy subjects matched to Group A | Experimental | Not described Receives: Drug: Elinogrel |
| C-Patients with moderate renal impairment | Experimental | Not described Receives: Drug: Elinogrel |
| D-Healthy subjects matched to Group C | Experimental | Not described Receives: Drug: Elinogrel |
| E-Patients with severe renal impairment | Experimental | Not described Receives: Drug: Elinogrel |
| F-Healthy subjects matched to Group E | Experimental | Not described Receives: Drug: Elinogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of elinogrel and its metabolite
The PK parameters calculated for both elinogrel and PRT060301 were:
- AUC0-12h, Cmax, and Tmax on Day 1/Day 7 and T1/2, RACC \& CLR on Day 7
- For elinogrel only, CLss/F and Vss/F were also calculated
Measured: 7 days
Secondary outcomes (2)
Safety assessments will include vital signs, electrocardiograms and adverse events
Safety assessments consisted of collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug, and pregnancies, regular monitoring of hematology, blood chemistry and urinalysis performed at study center. Safety assessments also included periodic ECG evaluations, assessments of vital signs, physical condition, and body weight.
Measured: 9 days
Measures of platelet function
Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portola Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Investigators
- Matthew W McClure, MD, Study director, Portola Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984113
- Sponsor's protocol ID
- 07-115 / CPRT128A2104
- Status last verified
- Aug 2023
- First submitted
- 16 Sep 2009
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of Elinogrel and Its Metabolite in Patients With Mild, Moderate, and Severe Renal Impairment Compared to Healthy Subjects
- ClinicalTrials.gov ID
- NCT00984113
- Acronym / sponsor ID
- 07-115 / CPRT128A2104
- Conditions
- Renal Impairment
- Keywords
- Elinogrel, Renal impairment, Healthy, Kidney dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Portola PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Sep 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.
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.
Detailed description
Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects.
- mild renal impairment: CrCl from 50 to ≤80 ml/min
- moderate renal impairment: CrCl from 30 to <50 ml/min
- severe renal impairment: CrCl of <30 ml/min
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A-Patients with mild renal impairment | Experimental | Drug: Elinogrel |
| B-Healthy subjects matched to Group A | Experimental | Drug: Elinogrel |
| C-Patients with moderate renal impairment | Experimental | Drug: Elinogrel |
| D-Healthy subjects matched to Group C | Experimental | Drug: Elinogrel |
| E-Patients with severe renal impairment | Experimental | Drug: Elinogrel |
| F-Healthy subjects matched to Group E | Experimental | Drug: Elinogrel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to understand and sign the written informed consent
- Subjects should have either normal renal function or have stable renal disease
Key exclusion criteria (2 listed)
- History of heart disease
- Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
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 |
|---|---|---|
| ElinogrelAlso: PRT060128100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany) | Drug | A-Patients with mild renal impairment, B-Healthy subjects matched to Group A, C-Patients with moderate renal impairment, D-Healthy subjects matched to Group C, E-Patients with severe renal impairment, F-Healthy subjects matched to Group E |
Primary outcome
Pharmacokinetics of elinogrel and its metabolite
Time frame: 7 days
The PK parameters calculated for both elinogrel and PRT060301 were: * AUC0-12h, Cmax, and Tmax on Day 1/Day 7 and T1/2, RACC \& CLR on Day 7 * For elinogrel only, CLss/F and Vss/F were also calculated
2 secondary outcomes
Safety assessments will include vital signs, electrocardiograms and adverse events
Time frame: 9 days
Measures of platelet function
Time frame: 7 days
Results and safety
The study was stopped early (reason given: For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
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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.
Matthew W McClure, MD study director
Portola Pharmaceuticals Inc.
2 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 Elinogrel in people with Renal Impairment, run by Portola Pharmaceuticals at 2 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Aug 2023. 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 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 was stopped early (reason given: For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data). Results are not available in the source record.
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?
Pharmacokinetics of elinogrel and its metabolite (time frame: 7 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 4 Aug 2023.