Glomerular Filtration RatePhase 1Pilot 1ANCT02098174
Pharmacokinetics of MP-3180 in Healthy Volunteers
A Phase 1 study testing MP-3180 and Iohexol comparator in people with Glomerular Filtration Rate and Acute Kidney Injury, run by MediBeacon at 1 site in United States.
Trial summary
The purpose of this study was to investigate the pharmacokinetics of MP-3180 (1 µmol/kg) compared to the pharmacokinetics of iohexol (5 mL of a 300 mg iodine (I)/mL solution) in healthy adult participants. The secondary objective was to evaluate the safety and tolerability of MP-3180 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glomerular Filtration Rate, Acute Kidney Injury
- What is being tested?
- MP-3180 and Iohexol comparator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Age: 22 years of age or older
- 2. Sex: males and not of childbearing potential females
- 3. Capable of informed consent
- 4. Weight restrictions:
- a. at least 50 kg (110 lbs) for men
- b. at least 48 kg (106 lbs) for women
- c. All participants will have a Body Mass Index (BMI) less than or equal to 33 but greater than or equal to 19
- 5. All participants should be judged by the Principal Investigator or Medical Sub-Investigator physician as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication
Who cannot join
- 1. Institutionalized participants will not be used
- 2. Social habits:
- a. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- b. Ingestion of any vitamins or herbal supplement within 7 day prior to the initial dose of study medication.
- c. Any significant change in dietary or exercise habits within the 48 hours prior to the initial dose of study medication.
- d. History of drug and/or alcohol abuse within the past year, unless currently enrolled in an abstinence program.
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- 3. Use of any prescription or over-the-counter (OTC) medications within the 7 days prior to the initial dose of study medication.
- 4. History of any significant cardiovascular disease, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic (including any history of seizure disorder), psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
- 5. Acute illness at the time of either the pre-study medical evaluation or dosing.
- 6. Not within normal limits or clinically significant for lab testing
- 7. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the participant from safely participating in the study.
- 8. Donation or loss of blood or plasma: 50 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication.
- 9. Intolerance to venipuncture.
- 10. Participants who have received an investigational drug within 30 days prior to the initial dose of study medication.
- 11. History of allergy or hypersensitivity to MP-3180 or iohexol, or other related products, or any of the inactive ingredients.
- 12. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the participant's participation in this study.
- 13. History of allergy or hypersensitivity to iodine containing contrast media or drugs.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate the pharmacokinetics of MP-3180 (1 µmol/kg) compared to the pharmacokinetics of iohexol (5 mL of a 300 mg iodine (I)/mL solution) in healthy adult participants. The secondary objective was to evaluate the safety and tolerability of MP-3180 in healthy adult participants.
Read the detailed description
Single-dose pharmacokinetics were characterized in sixteen (16) healthy, adult male participants in this Phase 1, open-label study following the administration of a single, intravenous 1 µmol/kg dose over 2 minutes followed by 10 mL saline under fasting conditions. Iohexol (Omnipaque-300, 5 mL of a 300 mg I/mL solution) was also administered over 2 minutes followed by 10 mL of saline. The pharmacokinetics of MP-3180 and iohexol was assessed by statistical comparison of pharmacokinetic parameters derived from plasma concentration-time curves and urine recovery data.
- Conditions
- Glomerular Filtration Rate, Acute Kidney Injury
- Being tested
- MP-3180, Iohexol comparator
- Keywords
- Glomerular Filtration Rate, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP-3180Drug
MP-3180 (1 µmol/kg or 0.372 mg/kg) (fluorescent tracer agent) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
Iohexol comparatorOther
Iohexol (Omnipaque 300, 5 mL) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | MP-3180 (1 µmol/kg or 0.372 mg/kg) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes. The iohexol comparator (Omnipaque 300, 5 mL) was then administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes. Receives: Drug: MP-3180; Other: Iohexol comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total plasma clearance of MP-3180 and iohexol
Blood samples were collected and analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.
Measured: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Renal clearance of MP-3180 and iohexol
Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.
Measured: Pre-dose and each time the participant voided up to 720 minutes post dose
Maximum Plasma Concentration (Cmax) for MP-3180 and iohexol
Blood samples were collected and analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.
Measured: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Time to Maximum Plasma Concentration (Tmax) for MP-3180 and iohexol
Blood samples were collected and analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data.
Measured: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
The terminal rate constant for MP-3180 and iohexol
Blood samples were collected and analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.
Measured: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration for MP-3180 and iohexol
Blood samples were collected and analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*hr/mL) was estimated from time 0 to the last measurable concentration using noncompartmental analyses.
Measured: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Area under the plasma concentration-time curve from time zero to infinity for MP-3180 and iohexol
Blood samples were collected and analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*hr/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.
Measured: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
The elimination half-life of MP-3180 and iohexol
Blood samples were collected and analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.
Measured: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Secondary outcomes (2)
Incidence of adverse events
An adverse event (AE) was defined as any untoward medical occurrence in a study subject after study drug administration and that did not necessarily have a causal relationship with this treatment.
Measured: 1, 3, and 8 hours after dosing, and within 2 weeks after the final study dose
Number of laboratory values that fall outside of pre-specified normal ranges
Blood samples were collected and analyzed for hematology and clinical chemistry. Out of range values were documented.
Measured: Pre-dose and within 2 weeks after the final study dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerular Filtration RateStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediBeacon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Dowling, Ph.D., Principal investigator, University of MarylandRichard B. Dorshow, Ph.D., Study director, MediBeacon, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098174
- Sponsor's protocol ID
- ORFM-1A
- Acronym
- Pilot 1A
- Status last verified
- Sep 2016
- First submitted
- 21 Mar 2014
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of MP-3180 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02098174
- Acronym / sponsor ID
- Pilot 1A / ORFM-1A
- Conditions
- Glomerular Filtration Rate, Acute Kidney Injury
- Keywords
- Glomerular Filtration Rate, Acute kidney injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- MediBeaconIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Mar 2014 (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 was to investigate the pharmacokinetics of MP-3180 (1 µmol/kg) compared to the pharmacokinetics of iohexol (5 mL of a 300 mg iodine (I)/mL solution) in healthy adult participants. The secondary objective was to evaluate the safety and tolerability of MP-3180 in healthy adult participants.
Detailed description
Single-dose pharmacokinetics were characterized in sixteen (16) healthy, adult male participants in this Phase 1, open-label study following the administration of a single, intravenous 1 µmol/kg dose over 2 minutes followed by 10 mL saline under fasting conditions. Iohexol (Omnipaque-300, 5 mL of a 300 mg I/mL solution) was also administered over 2 minutes followed by 10 mL of saline. The pharmacokinetics of MP-3180 and iohexol was assessed by statistical comparison of pharmacokinetic parameters derived from plasma concentration-time curves and urine recovery data.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Drug: MP-3180, Other: Iohexol comparatorMP-3180 (1 µmol/kg or 0.372 mg/kg) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes. The iohexol comparator (Omnipaque 300, 5 mL) was then administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Age: 22 years of age or older
- 2. Sex: males and not of childbearing potential females
- 3. Capable of informed consent
- 4. Weight restrictions:
- 5. All participants should be judged by the Principal Investigator or Medical Sub-Investigator physician as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication
Key exclusion criteria (17 listed)
- 1. Institutionalized participants will not be used
- 2. Social habits:
- 3. Use of any prescription or over-the-counter (OTC) medications within the 7 days prior to the initial dose of study medication.
- 4. History of any significant cardiovascular disease, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic (including any history of seizure disorder), psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
- 5. Acute illness at the time of either the pre-study medical evaluation or dosing.
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 |
|---|---|---|
| MP-3180MP-3180 (1 µmol/kg or 0.372 mg/kg) (fluorescent tracer agent) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes. | Drug | Healthy participants |
| Iohexol comparatorIohexol (Omnipaque 300, 5 mL) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes. | Other | Healthy participants |
Primary outcome
Total plasma clearance of MP-3180 and iohexol
Time frame: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Blood samples were collected and analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.
Renal clearance of MP-3180 and iohexol
Time frame: Pre-dose and each time the participant voided up to 720 minutes post dose
Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.
Maximum Plasma Concentration (Cmax) for MP-3180 and iohexol
Time frame: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Blood samples were collected and analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.
Time to Maximum Plasma Concentration (Tmax) for MP-3180 and iohexol
Time frame: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Blood samples were collected and analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data.
The terminal rate constant for MP-3180 and iohexol
Time frame: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Blood samples were collected and analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration for MP-3180 and iohexol
Time frame: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Blood samples were collected and analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*hr/mL) was estimated from time 0 to the last measurable concentration using noncompartmental analyses.
Area under the plasma concentration-time curve from time zero to infinity for MP-3180 and iohexol
Time frame: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Blood samples were collected and analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*hr/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.
The elimination half-life of MP-3180 and iohexol
Time frame: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Blood samples were collected and analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.
2 secondary outcomes
Incidence of adverse events
Time frame: 1, 3, and 8 hours after dosing, and within 2 weeks after the final study dose
Number of laboratory values that fall outside of pre-specified normal ranges
Time frame: Pre-dose and within 2 weeks after the final study 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 23 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Thomas Dowling, Ph.D. principal investigator
University of Maryland
Richard B. Dorshow, Ph.D. study director
MediBeacon, LLC
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 MP-3180 and Iohexol comparator in people with Glomerular Filtration Rate and Acute Kidney Injury, run by MediBeacon 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 8 inclusion and 17 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 23 Sep 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?
Total plasma clearance of MP-3180 and iohexol (time frame: Pre-dose and the following times after dosing: 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose). The study lists 8 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 23 Sep 2016.