A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)

What Was Tested

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

The effects of Bendavia on the volunteers will also be assessed.

It had four arms (groups): Placebo (placebo comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Healthy adult males or females aged between 18 and 65 years of age with signed informed consent.

The full record lists 3 inclusion and 21 exclusion criteria; among the exclusions: serum sodium level below the lower limit of the site's clinical laboratory normal range at the study qualification visit,; body weight less than 60 or greater than 80 kg and a body mass index of less than 18 kg/m2 or greater than 32 kg/m2,; history of seizures or history of epilepsy,.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got SS-31 (Elamipretide) and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received SS-31 (Elamipretide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-11 with completion listed for 2013-01.

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 Bendavia (ng/ml) in each cohort. Mean Half Life(t1/2) of Bendavia (hours) in each cohort.

It also tracked 6 secondary outcomes, for example Number of adverse events observed with and without Bendavia.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of SS-31 (Elamipretide) in 30 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.