Renal ImpairmentPhase 1NCT01359579
A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
A Phase 1 study testing varespladib methyl in people with Renal Impairment, run by Anthera Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- varespladib methyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2011to Jun 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive.
- Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae
Who cannot join
- Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- Evidence of significant respiratory, gastrointestinal or hepatic disease at screening
- Positive screen for hepatitis B surface antigen, or HIV
- Positive test in drugs of abuse screens or alcohol on admission to the clinic
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Investigator Site 103
Knoxville, Tennessee, 37920
Investigator Site 102
Minneapolis, Minnesota, 55404
Investigator Site 101
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-label, Pharmacokinetic, Safety, and Tolerability Study of a Single Oral Dose of Varespladib Methyl in Subjects With Normal Renal Function, and Subjects With Mild, Moderate, or Severe Renal Impairment
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.
- Conditions
- Renal Impairment
- Being tested
- varespladib methyl
- Keywords
- renal impairment, phase 1, healthy volunteers
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varespladib methylDrug
Single oral 500 mg dose
| Study group | Role | What they receive |
|---|---|---|
| Subjects with mild renal impairment | Experimental | Not described Receives: Drug: varespladib methyl |
| Subjects with moderate renal impairment | Experimental | Not described Receives: Drug: varespladib methyl |
| Subjects with normal renal function | Experimental | Not described Receives: Drug: varespladib methyl |
| Subjects with severe renal impairment | Experimental | Not described Receives: Drug: varespladib methyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
Measured: PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose
Secondary outcomes (1)
Safety measures to include adverse events and changes in clinical laboratory results
Measured: From admistration of study drug through follow-up on Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2012 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: Lack of efficacy
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359579
- Sponsor's protocol ID
- AN-CVD2213
- Status last verified
- Mar 2012
- First submitted
- 19 May 2011
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Pharmacokinetic, Safety, and Tolerability Study of a Single Oral Dose of Varespladib Methyl in Subjects With Normal Renal Function, and Subjects With Mild, Moderate, or Severe Renal Impairment
- ClinicalTrials.gov ID
- NCT01359579
- Acronym / sponsor ID
- AN-CVD2213
- Conditions
- Renal Impairment
- Keywords
- renal impairment, phase 1, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 25 May 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 compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects with mild renal impairment | Experimental | Drug: varespladib methyl |
| Subjects with moderate renal impairment | Experimental | Drug: varespladib methyl |
| Subjects with normal renal function | Experimental | Drug: varespladib methyl |
| Subjects with severe renal impairment | Experimental | Drug: varespladib methyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive.
- Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae
Key exclusion criteria (4 listed)
- Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- Evidence of significant respiratory, gastrointestinal or hepatic disease at screening
- Positive screen for hepatitis B surface antigen, or HIV
- Positive test in drugs of abuse screens or alcohol on admission to the clinic
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 |
|---|---|---|
| varespladib methylSingle oral 500 mg dose | Drug | Subjects with mild renal impairment, Subjects with moderate renal impairment, Subjects with normal renal function, Subjects with severe renal impairment |
Primary outcome
Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
Time frame: PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose
1 secondary outcome
Safety measures to include adverse events and changes in clinical laboratory results
Time frame: From admistration of study drug through follow-up on Day 8
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 varespladib methyl in people with Renal Impairment, run by Anthera 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 2 inclusion and 4 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 20 Mar 2012. 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 was stopped early (reason given: Lack of efficacy). 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?
Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function (time frame: PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose). 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 20 Mar 2012.