HealthyPhase 1NCT04154670
Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
A Phase 1 study testing MGTA-145 in people with Healthy and Renal Insufficiency, run by Ensoma at 2 sites in United States.
Trial summary
This study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment). Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Renal Insufficiency
- What is being tested?
- MGTA-145
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2019to 24 Mar 2020
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 to 79 years, inclusive, at the time of signing of the ICF.
- Body weight ≥50 kg and BMI 19 to 40 kg/m2, inclusive.
- Systolic blood pressure ≤170 mmHg and diastolic blood pressure ≤100 mmHg at Screening and Day 1.
- No clinically significant abnormalities on physical examination at Screening.
- Alanine aminotransferase and aspartate aminotransferase up to 1.5 x the upper limit of normal (ULN) as long as total bilirubin and alkaline phosphatase are ≤ ULN.
- No clinically significant abnormalities on ECG and QTcF <480 msec at Screening.
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- Female subjects are not pregnant, non-lactating, and must be of non-childbearing potential being either surgically sterile (eg, documented hysterectomy, bilateral oophorectomy, bilateral salpingo oopherectomy, tubal ligation) or post-menopausal women (over 45 years of age with 12 months or more amenorrhea verified by follicle stimulating hormone assessment and the absence of other biological or physiological causes).
- Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception (such as condom with spermicide) combined with an acceptable method of contraception for their non-pregnant female partner(s) after informed consent, throughout the study, and for a minimum of 90 days after the last dose, and who do not intend to donate sperm in the period from Screening until 3 months following administration of the study drug.
- Subject using medications known to affect the elimination of serum creatinine (eg, cimetidine, trimethoprim) within the past 30 days.
- Capable of providing informed consent and willing to comply with the requirements of the protocol.
- Specific inclusion criteria for subjects with NORMAL renal function:
- Estimated GFR (based on MDRD equation) ≥90 mL/min/1.73 m2 (normal) as determined by an average of 2 values obtained at least 48 hours apart within the previous 3 months.
- White blood cell (WBC) count, hemoglobin and platelet count within normal limits. Absolute neutrophil count of >1500/µL for African Americans and >2000/µL for other races.
- Specific inclusion criteria for subjects with RENAL IMPAIRMENT:
- Estimated GFR <90 mL/min/1.73 m2 (based on MDRD equation) as determined by an average of 2 values obtained at least 48 hours apart and within the previous 3 months.
- Stable renal function as determined by <20% difference in serum creatinine obtained on 2 occasions at least 48 hours apart and within the previous 3 months.
- Platelet count ≥100,000/mm3, hemoglobin count ≥10g/dL, WBC count within normal limits. Absolute neutrophil count of >1500/µL for African Americans and >2000/µL for other races.
Who cannot join
- Clinically significant abnormal finding on physical examination conducted at Screening. The assessment may be repeated once prior to treatment number assignment. If the repeat value(s) remains outside of protocol-specified ranges, the subject will be excluded from the study. Note: Re assessment is not allowed for subjects who have a positive urine drug screen test at Screening.
- History of chronic alcohol or drug abuse within the previous 12 months. Subject has a positive pre-study drug/alcohol screen (to include at minimum: amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepines, and myelosuppressive drugs). A subject with a positive finding on the drug screen may still be enrolled at the discretion of the Investigator if a plausible clinical explanation exists (eg, prior or concomitant medication use).
- History of kidney transplantation or requiring dialysis or anticipated to initiate dialysis during the study period.
- Donation of more than 500 mL of blood or plasma within 12 weeks prior to dosing.
- Subject smokes more than 10 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit.
- Acute illness, infection (requiring medical treatment [eg, antibiotics]), or surgery within 30 days of dosing.
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- Seropositive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus.
- Subject has received another investigational drug or participated in an investigational device study within 30 days prior to dosing.
- History of anaphylaxis or clinically important reaction to any drug including plerixafor.
- Specific exclusion criteria for subjects with NORMAL renal function:
- Any clinically significant laboratory value outside the normal range at Screening. The assessment may be repeated once prior to treatment number assignment. If the repeat value(s) remains outside of protocol-specified ranges, the subject will be excluded from the study. Note: Re assessment is not allowed for subjects who have a positive urine drug screen test at Screening.
- Any clinically significant hematologic, cardiovascular, pulmonary, central nervous system, metabolic, hepatic, or gastrointestinal conditions or history of conditions that, in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this study or may interfere with the interpretation of the study results.
- Subject has used any prescription drugs within 14 days prior to dosing or any dietary supplements or non prescription drugs within 7 days prior to dosing unless deemed acceptable by the Investigator and Sponsor (Magenta Medical Monitor).
- Specific exclusion criteria for subjects with RENAL IMPAIRMENT:
- Presence of acute kidney injury.
- Clinically significant laboratory abnormalities excluding those associated with renal impairment or the underlying cause of renal disease.
- Unstable medical condition or underlying medical condition that has changed within the past 90 days.
- Presence of laboratory abnormalities or clinically significant medical condition that in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this study or may interfere with the interpretation of the study results.
- Changes in prescription medications within 14 days prior to dosing or anticipated changes during the study period.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alliance for Multispeciality Research (AMR) Formerly New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809
About this study
Official title: An Open Label, Single Arm, Single Dose Study to Evaluate the Pharmacokinetics and Safety and Tolerability of MGTA 145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
This study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment).
Read the detailed description
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
- Conditions
- Healthy, Renal Insufficiency
- Being tested
- MGTA-145
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGTA-145Biological
MGTA-145 will be given intravenously
| Study group | Role | What they receive |
|---|---|---|
| Normal kidney function | Experimental | MGTA-145 single dose Receives: Biological: MGTA-145 |
| Mild decrease in GFR | Experimental | MGTA-145 single dose Receives: Biological: MGTA-145 |
| Moderate decrease in GFR | Experimental | MGTA-145 single dose Receives: Biological: MGTA-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Biomarkers
Investigate area under the curve (AUC)
Measured: 2 days
Pharmacokinetics Biomarkers
Investigate maximum plasma concentration (Cmax)
Measured: 2 days
Pharmacokinetics Biomarkers
Investigate clearance (CL)
Measured: 2 days
Pharmacokinetics Biomarkers
volume of distribution at steady state (Vdss)
Measured: 2 days
Pharmacokinetics Biomarkers
Investigate half-life
Measured: 2 days
Pharmacokinetics Biomarkers
Investigate renal clearance of MGTA-145
Measured: 2 days
Secondary outcomes (1)
Safety and Tolerability
Investigate the safety and tolerability of MGTA-145 following intravenous (IV) administration as monotherapy in subjects with varying degrees of renal impairment (e.g. adverse events, clinical laboratory tests, vital signs, ECGs)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start7 Nov 2019
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ensoma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Will Savage, MD, PhD, Study director, Magenta Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154670
- Sponsor's protocol ID
- 145-RI-102
- Status last verified
- Jan 2024
- First submitted
- 4 Nov 2019
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm, Single Dose Study to Evaluate the Pharmacokinetics and Safety and Tolerability of MGTA 145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT04154670
- Acronym / sponsor ID
- 145-RI-102
- Conditions
- Healthy, Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- EnsomaIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- 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 study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment).
Detailed description
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal kidney function | Experimental | Biological: MGTA-145MGTA-145 single dose |
| Mild decrease in GFR | Experimental | Biological: MGTA-145MGTA-145 single dose |
| Moderate decrease in GFR | Experimental | Biological: MGTA-145MGTA-145 single dose |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age from 18 to 79 years, inclusive, at the time of signing of the ICF.
- Body weight ≥50 kg and BMI 19 to 40 kg/m2, inclusive.
- Systolic blood pressure ≤170 mmHg and diastolic blood pressure ≤100 mmHg at Screening and Day 1.
- No clinically significant abnormalities on physical examination at Screening.
- Alanine aminotransferase and aspartate aminotransferase up to 1.5 x the upper limit of normal (ULN) as long as total bilirubin and alkaline phosphatase are ≤ ULN.
Key exclusion criteria (19 listed)
- Clinically significant abnormal finding on physical examination conducted at Screening. The assessment may be repeated once prior to treatment number assignment. If the repeat value(s) remains outside of protocol-specified ranges, the subject will be excluded from the study. Note: Re assessment is not allowed for subjects who have a positive urine drug screen test at Screening.
- History of chronic alcohol or drug abuse within the previous 12 months. Subject has a positive pre-study drug/alcohol screen (to include at minimum: amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepines, and myelosuppressive drugs). A subject with a positive finding on the drug screen may still be enrolled at the discretion of the Investigator if a plausible clinical explanation exists (eg, prior or concomitant medication use).
- History of kidney transplantation or requiring dialysis or anticipated to initiate dialysis during the study period.
- Donation of more than 500 mL of blood or plasma within 12 weeks prior to dosing.
- Subject smokes more than 10 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit.
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 |
|---|---|---|
| MGTA-145MGTA-145 will be given intravenously | Biological | Mild decrease in GFR, Moderate decrease in GFR, Normal kidney function |
Primary outcome
Pharmacokinetics Biomarkers
Time frame: 2 days
Investigate area under the curve (AUC)
Pharmacokinetics Biomarkers
Time frame: 2 days
Investigate maximum plasma concentration (Cmax)
Pharmacokinetics Biomarkers
Time frame: 2 days
Investigate clearance (CL)
Pharmacokinetics Biomarkers
Time frame: 2 days
volume of distribution at steady state (Vdss)
Pharmacokinetics Biomarkers
Time frame: 2 days
Investigate half-life
Pharmacokinetics Biomarkers
Time frame: 2 days
Investigate renal clearance of MGTA-145
1 secondary outcome
Safety and Tolerability
Time frame: 15 days
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 11 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Will Savage, MD, PhD study director
Magenta Therapeutics
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 MGTA-145 in people with Healthy and Renal Insufficiency, run by Ensoma 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 17 inclusion and 19 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 11 Jan 2024. 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 Biomarkers (time frame: 2 days). The study lists 6 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 11 Jan 2024.