NCT02637284: BPC-157 Phase 1 Clinical Trial Explained
NCT02637284 is a Phase 1 clinical trial of an oral BPC-157 formulation, registered on ClinicalTrials.gov in December 2015. It was designed as a randomised, placebo-controlled safety study in healthy volunteers. Its status is recorded as unknown, and in the ten years since registration, no results have ever been made public.
Trial at a glance
Why does this trial matter?
This was the first registered clinical trial of BPC-157 on ClinicalTrials.gov, and the only one to test an oral formulation. Had it been completed and published, it would have provided the first modern controlled human data on BPC-157. Instead, its fate is unknown, which is itself an important part of the BPC-157 story.
What was the trial testing?
The safety of an oral tablet formulation called PCO-02, whose active ingredient is BPC-157 (also designated Bepecin), and how the compound is absorbed and processed by the body: its pharmacokinetics. It was not designed to test whether BPC-157 treats any condition.
How was the trial designed?
Healthy adults aged 18 to 35 were to be randomly assigned to receive either the BPC-157 tablets or identical placebo tablets, with neither participants nor researchers knowing who received which. The design had two stages: a single-dose stage and a repeated-dose stage over two weeks. The trial planned to enrol 42 volunteers, was sponsored by PharmaCotherapia d.o.o. with a hospital in Tijuana, Mexico listed as collaborator, and was listed as starting in October 2015 with an estimated completion of March 2016.
What was the trial designed to measure?
- Safety: whether the tablets caused any adverse effects in healthy volunteers.
- Pharmacokinetics: how BPC-157 is absorbed, distributed and eliminated when taken by mouth.
Are results available?
No. The registry entry was last updated in December 2015 and last verified by the sponsor in October 2015. Its overall status is recorded as unknown, with a last known status of active, not recruiting. No results have been posted in the ten years since, and no publication from this trial has been identified.
What can be concluded now?
Only that a placebo-controlled trial of oral BPC-157 was planned and, at last report, underway. Without results, nothing can be concluded about what it found, or whether it was completed at all. When a trial goes silent for a decade, no conclusion can responsibly be drawn in either direction.
What this trial does not prove
- Registration does not prove the trial was completed.
- It does not prove oral BPC-157 is safe.
- It does not prove BPC-157 works.
- The absence of results is not evidence of what the results were.
Evidence strength
Research compound studied
BPC-157
This trial investigates BPC-157, a synthetic peptide of 15 amino acids. Batch-tested BPC-157 with certificates of analysis is available from our catalogue.
Sold for laboratory research use only. Not for human consumption. Nothing on this page is a claim that any product treats or prevents any condition.
How does this fit with other BPC-157 human research?
This trial and the oral route it tested are covered further in our oral BPC-157 guide. The wider human record includes three small published reports and further registered trials. View all BPC-157 clinical trials and human studies →
Primary registry record
PharmaCotherapia d.o.o. PCO-02: Safety and Pharmacokinetics Trial. ClinicalTrials.gov identifier NCT02637284. First posted 22 December 2015.
View the ClinicalTrials.gov record →