A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Subject is ≥18 years-of-age at the Screening Visit.
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Subject has signed an ICF before any study specific procedures are performed.
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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
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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.
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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.
Exclusion criteria
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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.
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Female subjects who are pregnant, planning to become pregnant, or lactating.
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Subject has history of cancer (with the exception of non-melanoma skin cancer), unless the subject has documentation of completed curative treatment
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Subject has history of renal transplantation.
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Subject has active inflammatory renal disease.
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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.
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Subject has positive serology for HIV 1, HIV 2, HBsAg or HCV.
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Subject has donated or received blood or blood products within the past 30 days.
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Subject participated in a clinical study involving investigational product within 30 days prior to the planned date of study drug administration.
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Subject has a history of clinically significant hypersensitivity or allergy to any of the excipients contained in the study drug.
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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 design
Primary purpose
Allocation
Interventional model
Masking
23 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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