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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
23
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with normal renal function.
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with mild renal impairment.
MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with moderate renal impairment
Unnamed facility
Maimi, Florida, United States
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
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MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with severe renal impairment