Normal and Impaired Renal FunctionPhase 1NCT02436447
A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function
A Phase 1 study testing MTP-131 in people with Normal and Impaired Renal Function, run by Stealth BioTherapeutics Inc. at 1 site in United States.
Trial summary
This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18 years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous infusion of MTP-131 administered for 7 consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal and Impaired Renal Function
- What is being tested?
- MTP-131
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Oct 2015
- 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
- Subject is ≥18 years-of-age at the Screening Visit.
- Subject has signed an ICF before any study specific procedures are performed.
- Subjects selected for each cohort must satisfy the following creatinine clearance (CLCR) criteria (as determined by 24 hour urine collection and analysis):
- Cohort 1 - Normal Renal Function, 24 hour CLCR ≥ 90 mL/min
- Cohort 2 - Mild renal impairment, 24 hour CLCR ≥ 60-89 mL/min
- Cohort 3 - Moderate renal impairment, 24 hour CLCR ≥ 30-59 mL/min
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- Cohort 4 - Severe renal impairment, 24 hour CLCR <30 not requiring dialysis
- Have a history of stable renal impairment as determined by standard estimated creatinine clearance methodology (at least 1 month within the same descriptive cohort) and be in a stable physical condition based on findings of medical history.
- Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until two months after the last dose of study drug:
- Abstinence, when it is in line with the preferred and usual lifestyle of the subject. Subject agrees to use an acceptable method of contraception should they become sexually active.
- Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy (the vasectomy procedure must have been conducted at least 60 days prior to the Screening Visit or confirmed via sperm analysis).
- Barrier method (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream AND either hormonal contraception (oral, implanted, or injectable) or an intrauterine device or system.
Who cannot join
- Subject has history of any concurrent medical condition which, in the opinion of the investigator, significantly increases the potential risks associated with administration of MTP-131 or any other aspect of study participation, with the exception of renal impairment.
- Female subjects who are pregnant, planning to become pregnant, or lactating.
- Subject has history of cancer (with the exception of non-melanoma skin cancer), unless the subject has documentation of completed curative treatment
- Subject has history of renal transplantation.
- Subject has active inflammatory renal disease.
- Subject has a history of histamine intolerance (e.g., a known deficiency of endogenous or exogenous histamine degradation).
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- Subject is currently receiving treatment with chemotherapeutic agents or immunosuppressant agents.
- Subject has positive serology for HIV 1, HIV 2, HBsAg or HCV.
- Subject has donated or received blood or blood products within the past 30 days.
- Subject participated in a clinical study involving investigational product within 30 days prior to the planned date of study drug administration.
- Subject has a history of clinically significant hypersensitivity or allergy to any of the excipients contained in the study drug.
- Subject has a history of active alcoholism or drug addiction during the year before the Screening Visit.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 7 Day Repeat Dose, Parallel-Group, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Intravenous Infusion of MTP-131 Administered in Subjects With Impaired Renal Function
This study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18 years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous infusion of MTP-131 administered for 7 consecutive days. Twenty-four subjects are planned to be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6 subjects.
- Conditions
- Normal and Impaired Renal Function
- Being tested
- MTP-131
- Keywords
- Renal Impairment, Renal function, MTP-131, Bendavia™
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTP-131Drug
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with normal renal function.
MTP-131Drug
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with mild renal impairment.
MTP-131Drug
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with moderate renal impairment
MTP-131Drug
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with severe renal impairment
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Experimental | Not described Receives: Drug: MTP-131 |
| Mild renal impairment | Experimental | Not described Receives: Drug: MTP-131 |
| Moderate renal impairment | Experimental | Not described Receives: Drug: MTP-131 |
| Severe renal impairment | Experimental | Not described Receives: Drug: MTP-131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
Measured: Assessed up to Day 14
Secondary outcomes (1)
Incidence of Adverse Events
Measured: Assessed up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal and Impaired Renal FunctionStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stealth BioTherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436447
- Sponsor's protocol ID
- SPICP-101
- Status last verified
- Nov 2015
- First submitted
- 30 Apr 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 7 Day Repeat Dose, Parallel-Group, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Intravenous Infusion of MTP-131 Administered in Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT02436447
- Acronym / sponsor ID
- SPICP-101
- Conditions
- Normal and Impaired Renal Function
- Keywords
- Renal Impairment, Renal function, MTP-131, Bendavia™
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stealth BioTherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 May 2015 (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 study is a Phase 1, open-label, parallel group, multiple dose study, in subjects over 18 years, to evaluate the safety, tolerability, and pharmacokinetics of one-hour intravenous infusion of MTP-131 administered for 7 consecutive days. Twenty-four subjects are planned to be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6 subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Experimental | Drug: MTP-131 |
| Mild renal impairment | Experimental | Drug: MTP-131 |
| Moderate renal impairment | Experimental | Drug: MTP-131 |
| Severe renal impairment | Experimental | Drug: MTP-131 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is ≥18 years-of-age at the Screening Visit.
- Subject has signed an ICF before any study specific procedures are performed.
- Subjects selected for each cohort must satisfy the following creatinine clearance (CLCR) criteria (as determined by 24 hour urine collection and analysis):
- Have a history of stable renal impairment as determined by standard estimated creatinine clearance methodology (at least 1 month within the same descriptive cohort) and be in a stable physical condition based on findings of medical history.
- Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until two months after the last dose of study drug:
Key exclusion criteria (13 listed)
- Subject has history of any concurrent medical condition which, in the opinion of the investigator, significantly increases the potential risks associated with administration of MTP-131 or any other aspect of study participation, with the exception of renal impairment.
- Female subjects who are pregnant, planning to become pregnant, or lactating.
- Subject has history of cancer (with the exception of non-melanoma skin cancer), unless the subject has documentation of completed curative treatment
- Subject has history of renal transplantation.
- Subject has active inflammatory renal disease.
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 |
|---|---|---|
| MTP-131MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with normal renal function. | Drug | Normal renal function |
| MTP-131MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with mild renal impairment. | Drug | Mild renal impairment |
| MTP-131MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with moderate renal impairment | Drug | Moderate renal impairment |
| MTP-131MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with severe renal impairment | Drug | Severe renal impairment |
Primary outcome
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
Time frame: Assessed up to Day 14
1 secondary outcome
Incidence of Adverse Events
Time frame: Assessed up to 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 18 Nov 2015.
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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.
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 MTP-131 in people with Normal and Impaired Renal Function, run by Stealth BioTherapeutics Inc. 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 12 inclusion and 13 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 18 Nov 2015. 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?
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort (time frame: Assessed up to Day 14). 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 18 Nov 2015.