DRUG
MTP-131
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with normal renal function.
Status
Completed
Phase
Phase 1
Enrollment
23
Locations
1
Results
Not posted
Publications
0
Study 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. Twenty-four subjects are planned to be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6 subjects.
Interventions
DRUG
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with normal renal function.
DRUG
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with mild renal impairment.
DRUG
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with moderate renal impairment
DRUG
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with severe renal impairment
Timeline
First posted
May 6, 2015
Study start
May 2015
Primary completion
Jul 2015
Study completion
Oct 2015
Results posted
Not reported
Registry updated
Nov 18, 2015
Outcomes
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
Time frame · Assessed up to Day 14
Incidence of Adverse Events
Time frame · Assessed up to Day 14
Eligibility
Inclusion Criteria: * 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 * 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: 1. 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. 2. 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). 3. 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. Exclusion Criteria: * 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). * 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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Maimi, Florida, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Stealth BioTherapeutics Inc. · Barth Syndrome
Phase 4
Recruiting
48
2026-07
Stealth BioTherapeutics Inc. · Age Related Macular Degeneration (ARMD)
Phase 3
Active, not recruiting
313
2026-05
Children's Hospital of Philadelphia · Friedreich Ataxia
Phase 1 / Phase 2
Completed
20
2025-12
David Marcinek · Aging, Healthy
Phase 2
Recruiting
30
2025-12
Stealth BioTherapeutics Inc. · Mitochondrial Myopathies · Mitochondrial Pathology
Phase 3
Completed
102
2025-10
Stealth BioTherapeutics Inc. · Mitochondrial Diseases · Barth Syndrome
Not applicable
Available
—
2025-02
Stealth BioTherapeutics Inc. · Age-related Macular Degeneration
Phase 2
Completed
176
2024-07
Stealth BioTherapeutics Inc. · Barth Syndrome
Phase 2 / Phase 3
Completed
12
2024-04
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.