PCO-02 - Safety and Pharmacokinetics Trial
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| ClinicalTrials.gov Identifier: NCT02637284 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Volunteers | Drug: Bepecin Drug: Placebo | Phase 1 |
Show detailed description
| 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 |
|---|---|
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Experimental: Intervention 1a (cohort 1)
Single dose of 1 oral tablet of PCO-02 containing 1 mg of Bepecin (12 subjects)
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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 |
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Experimental: Intervention 1a (cohort 2)
Single dose of 3 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)
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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 |
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Experimental: Intervention 1a (cohort 3)
Single dose of 6 oral tablets of PCO-02 containing 1 mg of Bepecin (12 subjects)
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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 |
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Placebo Comparator: Control group 1a (cohort 1)
Single dose of 1 oral tablet of PCO-03 as placebo (2 subjects)
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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 |
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Placebo Comparator: Control group 1a (cohort 2)
Single dose of 3 oral tablets of PCO-03 as placebo (2 subjects)
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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 |
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Placebo Comparator: Control group 1 a (cohort 3)
Single dose of 6 oral tablets of PCO-03 as placebo by mouth (2 subjects)
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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 |
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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)
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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 |
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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)
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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 |
- Adverse events [ Time Frame: Six months ]Any adverse event reported during the study.
- Maximum plasma concentration [ Time Frame: 168 hours ]Cmax
- Time to maximum plasma concentration [ Time Frame: 168 hours ]Tmax
- Area under the curve [ Time Frame: 168 hours ]AUC
- Elimination half life [ Time Frame: 168 hours ]T1/2
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
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
| Mexico | |
| Hospital Ángeles Tijuana | |
| Tijuana, Baja California, Mexico, 22010 | |
| Principal Investigator: | Rufino Menchaca, PhD | Hospital Ángeles Tijuana |
| Responsible Party: | PharmaCotherapia d.o.o. |
| ClinicalTrials.gov Identifier: | NCT02637284 |
| 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 |
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Healthy volunteers |
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BPC 157 Anti-Ulcer Agents Gastrointestinal Agents |

