PCO-02 - Safety and Pharmacokinetics Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 28 December 2015
• Main ID: NCT02637284
• Date of registration: 15/12/2015
• Prospective Registration: No
• Primary sponsor: PharmaCotherapia d.o.o.
• Public title: PCO-02 - Safety and Pharmacokinetics Trial
• Scientific 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.
• Date of first enrolment: October 2015
• Target sample size: 42
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02637284
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Mexico

Contacts

• Name: Rufino Menchaca, PhD
• Affiliation: Hospital Ángeles Tijuana

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: Bepecin

Drug: Placebo

Primary Outcome(s)

Adverse events [Time Frame: Six months]

Secondary Outcome(s)

Maximum plasma concentration [Time Frame: 168 hours]

Area under the curve [Time Frame: 168 hours]

Elimination half life [Time Frame: 168 hours]

Time to maximum plasma concentration [Time Frame: 168 hours]

Secondary ID(s)

SPK-1A/B-1.3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital Ángeles Tijuana