Trial · Interventional
CompletedPhase 1Registry dataA Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 23 participants (actual)
- Sponsor
- Stealth BioTherapeutics Inc. · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- May 2015
- Primary completion
- Jul 2015
- Completion
- Oct 2015
- First posted
- 6 May 2015 (estimated)
- Last update posted
- 18 Nov 2015 (estimated)
- Conditions
- Normal and Impaired Renal Function
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function
NCT02436447May 2015 to Oct 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
- MTP-131Drug
- MTP-131Drug
- MTP-131Drug
- MTP-131Drug
Arms4
Experimental
Normal renal function
Experimental
Mild renal impairment
Experimental
Moderate renal impairment
Experimental
Severe renal impairment
Primary outcomes1
Outcomes the sponsor listed as primary.
Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort
Time frame · Assessed up to Day 14
Secondary outcomes(1)
Incidence of Adverse Events
Time frame · Assessed up to Day 14
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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