Skip to content

Trial · Interventional

Status unknownPhase 1Registry data

PCO-02 - Safety and Pharmacokinetics Trial

NCTNCT02637284 (opens ClinicalTrials.gov in a new tab)Other idSPK-1A/B-1.3
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 1
Enrollment
42 participants (estimated)
Sponsor
PharmaCotherapia d.o.o. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Mexico

Start
Oct 2015
Primary completion
Feb 2016 (estimated)
Completion
Mar 2016 (estimated)
First posted
22 Dec 2015 (estimated)
Last update posted
22 Dec 2015 (estimated)
Conditions
Healthy Volunteers

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 1

    PCO-02 - Safety and Pharmacokinetics Trial

    NCT02637284

    Oct 2015 to est. Mar 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.

Interventions

  • BepecinDrug
  • PlaceboDrug

Arms8

  • Experimental

    Intervention 1a (cohort 1)

    Single dose of 1 oral tablet of PCO-02 containing 1 mg of Bepecin (12 subjects)

  • Experimental

    Intervention 1a (cohort 2)

    Single dose of 3 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)

  • Experimental

    Intervention 1a (cohort 3)

    Single dose of 6 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)

  • Placebo comparator

    Control group 1a (cohort 1)

    Single dose of 1 oral tablet of PCO-03 as placebo (2 subjects)

  • Placebo comparator

    Control group 1a (cohort 2)

    Single dose of 3 oral tablets of PCO-03 as placebo (2 subjects)

  • Placebo comparator

    Control group 1 a (cohort 3)

    Single dose of 6 oral tablets of PCO-03 as placebo by mouth (2 subjects)

  • Experimental

    Intervention 1b

    Multiple dose regime of 3 oral tablets of PCO-02 containing 1 mg Bepecin every 8 hours during 2 weeks (36 subjects)

  • Placebo comparator

    Control group 1b

    Multiple dose regime of 3 oral tablets of PCO-03 as placebo every 8 hours during 2 weeks (6 subjects)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Adverse events

    Time frame · Six months

    Registry description

    Any adverse event reported during the study.

Secondary outcomes(4)

  1. Maximum plasma concentration

    Time frame · 168 hours

    Registry description

    Cmax

  2. Time to maximum plasma concentration

    Time frame · 168 hours

    Registry description

    Tmax

  3. Area under the curve

    Time frame · 168 hours

    Registry description

    AUC

  4. Elimination half life

    Time frame · 168 hours

    Registry description

    T1/2

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 35 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 blood work, according to following criteria: Leucocytes \>3,000; Platelets \>100,000; Hemoglobin \>10.0 g/dL; AST, ALT and bilirubin \< 2 times UNL; Creatinine \< 2 times UNL. * 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). * Willing to return for follow-up as required by the study. Exclusion Criteria: * History of psychiatric condition. * Pregnant or lactating women. * Clinically significant abnormalities on the ECG. * Presence of medical or social conditions that, in opinion of the investigator, may prevent the proper participation of the volunteer subject in the study or in the assessment of its outcomes. * Presence of an active systemic infection. * Subjects receiving medical treatment for any medical condition, either acute or chronic. * Recent (\< 6 months) major surgery. * Recent (\< 1 year) alcohol abuse or illegal drug use.

PepBank is a research reference. Talk to a doctor before you use any peptide.