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PCO-02 - Safety and Pharmacokinetics Trial

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ClinicalTrials.gov Identifier: NCT02637284
Recruitment Status : Unknown
Verified October 2015 by PharmaCotherapia d.o.o..
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Collaborator:
Hospital Ángeles Tijuana
Information provided by (Responsible Party):
PharmaCotherapia d.o.o.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Bepecin Drug: Placebo Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Phase I, Pilot Study in Healthy Volunteers, to Assess the Safety and Pharmacokinetics of PCO-02, Which Active Ingredient is BPC-157, a Penta-deca-peptide From Gastric Source.
Study Start Date : October 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Intervention 1a (cohort 1)
Single dose of 1 oral tablet of PCO-02 containing 1 mg of Bepecin (12 subjects)
Drug: Bepecin

Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.

Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

Other Name: PCO-02, BPC-157

Experimental: Intervention 1a (cohort 2)
Single dose of 3 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)
Drug: Bepecin

Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.

Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

Other Name: PCO-02, BPC-157

Experimental: Intervention 1a (cohort 3)
Single dose of 6 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)
Drug: Bepecin

Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.

Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

Other Name: PCO-02, BPC-157

Placebo Comparator: Control group 1a (cohort 1)
Single dose of 1 oral tablet of PCO-03 as placebo (2 subjects)
Drug: Placebo

Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.

Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.

Other Name: PCO-03

Placebo Comparator: Control group 1a (cohort 2)
Single dose of 3 oral tablets of PCO-03 as placebo (2 subjects)
Drug: Placebo

Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.

Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.

Other Name: PCO-03

Placebo Comparator: Control group 1 a (cohort 3)
Single dose of 6 oral tablets of PCO-03 as placebo by mouth (2 subjects)
Drug: Placebo

Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.

Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.

Other Name: PCO-03

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)
Drug: Bepecin

Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.

Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

Other Name: PCO-02, BPC-157

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)
Drug: Placebo

Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.

Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.

Other Name: PCO-03




Primary Outcome Measures :
  1. Adverse events [ Time Frame: Six months ]
    Any adverse event reported during the study.


Secondary Outcome Measures :
  1. Maximum plasma concentration [ Time Frame: 168 hours ]
    Cmax

  2. Time to maximum plasma concentration [ Time Frame: 168 hours ]
    Tmax

  3. Area under the curve [ Time Frame: 168 hours ]
    AUC

  4. Elimination half life [ Time Frame: 168 hours ]
    T1/2



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637284


Locations
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Mexico
Hospital Ángeles Tijuana
Tijuana, Baja California, Mexico, 22010
Sponsors and Collaborators
PharmaCotherapia d.o.o.
Hospital Ángeles Tijuana
Investigators
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Principal Investigator: Rufino Menchaca, PhD Hospital Ángeles Tijuana

Additional Information:
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Responsible Party: PharmaCotherapia d.o.o.
ClinicalTrials.gov Identifier: NCT02637284     History of Changes
Other Study ID Numbers: SPK-1A/B-1.3
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: October 2015

Keywords provided by PharmaCotherapia d.o.o.:
Healthy volunteers

Additional relevant MeSH terms:
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BPC 157
Anti-Ulcer Agents
Gastrointestinal Agents