PCO-02 - Safety and Pharmacokinetics Trial

What Was Tested

In this phase 1 trial, researchers set out to test BPC-157.

It had eight arms (groups): Intervention 1a (cohort 1) (experimental), Intervention 1a (cohort 2) (experimental), Intervention 1a (cohort 3) (experimental), Control group 1a (cohort 1) (placebo comparator) and Control group 1a (cohort 2) (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Protocol Number: BPC-1A/B-1.2 Phase: I Population: Healthy subjects, males or females, between 18 and 35 years of age.

Duration of Study: Six months, from January 01, 2015 to Jun 30, 2015.

Randomization will be at a PCO-02-to-placebo ratio of 6:1 on each group, keeping a balance between men and women among groups.

A week after, subjects will return for clinical assessment and laboratory blood work to continue monitoring for AE's.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to people of any sex aged from 18 years up to 35 years.

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

Examples of who could join: Both genders, between the ages of 18 and 35 years old. Willing and able to provide informed consent. Body Mass Index between 18.5 and 24.9 (normal). Normal ECG and chest x-rays, at the discretion of the cardiologist and radiologist, respectively. Negative urine pregnancy test (Women in childbearing age, sexually active).

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: history of psychiatric condition; pregnant or lactating women; presence of an active systemic infection.

How the Study Was Run

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

Because people in this BPC-157 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The BPC-157 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 BPC-157.

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

It started in 2015-10 with completion listed for 2016-02.

It ran at 1 site in Mexico.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Adverse events (time frame: Six months).

It also tracked 4 secondary outcomes, for example Maximum plasma concentration, Time to maximum plasma concentration, Area under the curve and Elimination half life.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of BPC-157 in 42 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BPC-157 compound page, all human trials.