A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function

What Was Tested

The trial (phase 1) is built around SS-31 (Elamipretide).

Twenty-four subjects are planned to be enrolled into 4 cohorts of varying renal function, with each cohort consisting of 6 subjects.

It had four arms (groups): Normal renal function (experimental), Mild renal impairment (experimental), Moderate renal impairment (experimental) and Severe renal impairment (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 23 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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 4 - Severe renal impairment, 24 hour CLCR \<30 not requiring dialysis. 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.

The full record lists 12 inclusion and 13 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label SS-31 (Elamipretide) study: the participants and staff both knew the treatment.

It started in 2015-05 with completion listed for 2015-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Mean peak plasma concentration (Cmax) of MTP-131 (ng/ml) in each cohort (time frame: Assessed up to Day 14).

It also tracked 1 secondary outcome, for example Incidence of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of SS-31 (Elamipretide) in 23 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the SS-31 (Elamipretide) compound page, all human trials.