Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days

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 three arms (groups): one (experimental), Placebo (placebo comparator) and one (experimental).

Placebo (matching), once daily for 7 days.

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,; history of seizures or history of epilepsy,; history of serious (principal investigator judgment) mental illness,.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

The SS-31 (Elamipretide) group and the comparison group ran side by side rather than switching.

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 2013-02 with completion listed for 2013-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) on Day 1 in each cohort. Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) on Day 7 in each cohort. Mean time to peak plasma concentration (Tmax) of Bendavia (hr) on Day 1 in each cohort.

It also tracked 8 secondary outcomes, for example Ratio of AUC0-24h for M1 calculated on Day 7 to AUC0-24h calculated on Day 1 [AUC0-24h (d7)/AUC0-24h (d1)] and Ratio of AUC0-24h for M2 calculated on Day 7 to AUC0-24h calculated on Day 1 [AUC0-24h (d7)/AUC0-24h (d1)].

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.