NCT02436447

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, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Stealth BioTherapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normal and Impaired Renal Function

Interventions

Type	Name	Description
DRUG	MTP-131	MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with normal renal function.
DRUG	MTP-131	MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with mild renal impairment.
DRUG	MTP-131	MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with moderate renal impairment
DRUG	MTP-131	MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with severe renal impairment

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-07-01
• Completion: 2015-10-01
• First posted: 2015-05-06
• Last updated: 2015-11-18

Locations

1 site across 1 country: United States