PCO-02 - Safety and Pharmacokinetics Trial

NCT02637284 | Unknown Phase 1

• 1 other identifier: SPK-1A/B-1.3
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Any adverse event reported during the study.

  Six months

Secondary Outcomes (4)

• Maximum plasma concentration

  168 hours

• Time to maximum plasma concentration

  168 hours

• Area under the curve

  168 hours

• Elimination half life

  168 hours

Study Arms (8)

Intervention 1a (cohort 1)

EXPERIMENTAL

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

Drug: Bepecin

Intervention 1a (cohort 2)

EXPERIMENTAL

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

Drug: Bepecin

Intervention 1a (cohort 3)

EXPERIMENTAL

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

Drug: Bepecin

Control group 1a (cohort 1)

PLACEBO COMPARATOR

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

Drug: Placebo

Control group 1a (cohort 2)

PLACEBO COMPARATOR

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

Drug: Placebo

Control group 1 a (cohort 3)

PLACEBO COMPARATOR

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

Drug: Placebo

Intervention 1b

EXPERIMENTAL

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

Drug: Bepecin

Control group 1b

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bepecin DRUG

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.

Also known as: PCO-02, BPC-157

Intervention 1a (cohort 1); Intervention 1a (cohort 2); Intervention 1a (cohort 3); Intervention 1b

Placebo DRUG

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.

Also known as: PCO-03

Control group 1 a (cohort 3); Control group 1a (cohort 1); Control group 1a (cohort 2); Control group 1b

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaCotherapia d.o.o.: lead
• Hospital Ángeles Tijuana: collaborator

Study Sites (1)

Hospital Ángeles Tijuana

Tijuana, Estado de Baja California, 22010, Mexico

Location

Related Links

• Bepecin general information

MeSH Terms

Interventions

BPC 157

Study Officials

• Rufino Menchaca, PhD

  Hospital Ángeles Tijuana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 22, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 22, 2015

Record last verified: 2015-10

Locations

ME (1)