Pharmacokinetics of VepoloxamerPhase 1NCT02646358
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
A Phase 1 study testing Vepoloxamer in people with Pharmacokinetics of Vepoloxamer and Healthy Volunteers, run by Mast Therapeutics, Inc. at 2 sites in United States.
Trial summary
This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Vepoloxamer, Healthy Volunteers, Renal Impaired
- What is being tested?
- Vepoloxamer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Nov 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2
- Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days
- If female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration
- If male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration
- Considered by the Investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ECG and laboratory test results
- Non-smoker, or smokes fewer than 10 cigarettes/day
Who cannot join
- Uncontrolled medical condition (treated or untreated) considered to be clinically significant by the Investigator
- Experienced an illness considered by the Investigator to be clinically significant within 2 weeks of study drug administration
- Treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening
- Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1
- Donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DaVita Clinical Research
Lakewood, Colorado, 80228
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Vepoloxamer in Subjects With Varying Degrees of Renal Impairment and Healthy Matched Control Subjects With Normal Renal Function
This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.
- Being tested
- Vepoloxamer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VepoloxamerDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Normal Renal Function | Experimental | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours Receives: Drug: Vepoloxamer |
| Cohort 2: Mild Renal Impairment | Experimental | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours Receives: Drug: Vepoloxamer |
| Cohort 3: Moderate Renal Impairment | Experimental | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours Receives: Drug: Vepoloxamer |
| Cohort 4: Severe Renal Impairment | Experimental | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours Receives: Drug: Vepoloxamer |
| Cohort 5: End Stage Renal Disease | Experimental | Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours Receives: Drug: Vepoloxamer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics variable - Area under the plasma concentration curve
Measured: Time zero through 96 hours
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03
Measured: Time zero through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of VepoloxamerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwin L Parsley, DO, Study director, Mast Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646358
- Sponsor's protocol ID
- MST-188-10
- Status last verified
- Dec 2016
- First submitted
- 1 Jan 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Vepoloxamer in Subjects With Varying Degrees of Renal Impairment and Healthy Matched Control Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT02646358
- Acronym / sponsor ID
- MST-188-10
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (actual)
- First posted
- 5 Jan 2016 (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 is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Normal Renal Function | Experimental | Drug: VepoloxamerVepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 2: Mild Renal Impairment | Experimental | Drug: VepoloxamerVepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 3: Moderate Renal Impairment | Experimental | Drug: VepoloxamerVepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 4: Severe Renal Impairment | Experimental | Drug: VepoloxamerVepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 5: End Stage Renal Disease | Experimental | Drug: VepoloxamerVepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2
- Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days
- If female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration
- If male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration
- Considered by the Investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ECG and laboratory test results
Key exclusion criteria (5 listed)
- Uncontrolled medical condition (treated or untreated) considered to be clinically significant by the Investigator
- Experienced an illness considered by the Investigator to be clinically significant within 2 weeks of study drug administration
- Treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening
- Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1
- Donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration
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 |
|---|---|---|
| Vepoloxamer | Drug | Cohort 1: Normal Renal Function, Cohort 2: Mild Renal Impairment, Cohort 3: Moderate Renal Impairment, Cohort 4: Severe Renal Impairment, Cohort 5: End Stage Renal Disease |
Primary outcome
Pharmacokinetics variable - Area under the plasma concentration curve
Time frame: Time zero through 96 hours
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03
Time frame: Time zero through Day 14
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 22 Dec 2016.
- Individual participant dataSharing planned: Yes
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.
Edwin L Parsley, DO study director
Mast Therapeutics, 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 Vepoloxamer in people with Pharmacokinetics of Vepoloxamer and Healthy Volunteers, run by Mast Therapeutics, Inc. 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 6 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 22 Dec 2016. 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 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?
Pharmacokinetics variable - Area under the plasma concentration curve (time frame: Time zero through 96 hours). 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 22 Dec 2016.