Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia

NCT03663881 | Completed Phase 1

• 1 other identifier: CS001-SA
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity. The extract shows immunomodulatory activity in healthy animals and anti-tumor activity in animals with breast cancer and melanoma as well. The use of P2Et in animals with tumors shows a synergistic effect with doxorubicin in drug-resistant cell lines. In addition, an increase in survival of transplanted animals with a TS/A breast cancer tumor model and treated with P2Et, in conjunction with calreticulin increase is observed. This open-label, single arm, Phase 1 study intends to assess the safety of P2Et extract obtained from Caesalpinia spinosa, with dose escalation, in healthy voluntary participants in Colombia.

Conditions

Toxicity; Safety Issues

Keywords

Polyphenols; Safety; Herbal Extract

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  Identification of the maximum dose toxicity

  12 months

Secondary Outcomes (1)

• Immunomodulation

  12 months

Study Arms (1)

P2Et extract

EXPERIMENTAL

P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design.

Drug: P2Et extract

Interventions

P2Et extract DRUG

P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design.

Also known as: P2Et obtained from Caesalpinia spinosa

P2Et extract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Adequate renal, hematological, hepatic function defined as:
• Normal renal function defined as serum creatinine ≤ 1.5 mg/dl or creatinine clearance
• mL/min/1.73 m2 (according to local evaluation method).
• Hepatic function: alkaline phosphatase ≤ 2.5 × LSN, aspartate aminotransferase (AST) ≤ 2.5 × LSN, alanine aminotransferase ≤ 2.5 × LSN, total bilirubin ≤ 1.5 × LSN.
• Leukocyte count ≥3,000/mcL, neutrophils absolute count ≥ 1500/mm3 (1.5 × 109/L).
• Platelets ≥100,000/mm3 (100 × 109/L) and Hemoglobin ≥ 9.0 g/dL in peripheral blood.
• \- Cardiovascular function: No evidence of acute ischemic heart disease in the electrocardiogram.
• No uncontrolled or significant comorbidities determined by clinical history, physical examination and screening laboratory tests at the discretion of the investigator.
• Women of childbearing age must have a negative pregnancy test (urine or serum) at the time of screening and enrollment.
• Female subjects of childbearing age (those who have not been menopausal at least for 12 months or who have undergone surgical sterilization by bilateral tubal ligation procedure, bilateral oophorectomy or hysterectomy), and their male partners, must use at least one of the below mentioned contraceptive methods at the time of entering the study, throughout the study, and at least 6 months following the P3Et use (the effects of
• P2Et in the developing human fetus are unknown):
• Total abstinence of sexual intercourse, starting at least one complete menstrual cycle prior to the administration of the study drug; (it should be noted that: sexual abstinence as a contraceptive method must be limited to those cases in which it has been established as the pre-existent election of lifestyle by the patient);
• Vasectomized partner of a female subject.
• Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to the administration of the study drug;

You may not qualify if:

• Subjects with one or more of the following conditions are not eligible for this study.
• Subjects receiving any investigational agent and /or taking part in a clinical study in the 30 days prior to the admission or during their participation in the study.
• History of allergic reactions attributed to polyphenol-type compounds similar to those found in green tea.
• Use of dietary supplements or phytopharmaceutical drugs \< 15 days prior to the admission and during the study.
• Subjects with diagnosis of an active disease and/or receiving pharmacological treatment prescribed for an active disease and who have evidence of an active disease at the time of the initial clinical examination at the discretion of the investigator.
• Severe, active concomitant morbidity, including but not limited to:
• Moderate or severe liver failure (B or higher Child-Pugh category with qualification 7 or higher).
• Congestive heart failure grade II or higher according to New York Heart Association requiring hospitalization within 12 months prior to registration.
• Unstable angina and/or congestive heart disease within the previous 6 months
• Severe cardiac arrhythmia with no appropriate control.
• Antecedents of brain hemorrhage or stroke (ACV) or transient ischemic attack within the previous 6 months.
• Myocardial infarction within the previous 6 months.
• Subjects with a disease indicative of clinically defined Acquired Immunodeficiency Syndrome (AIDS). This is necessary in order to assure that those subjects can be more likely to be suitable to receive the full treatment.
• Any other major clinical disease or psychiatric disorder that, at the discretion of the investigator, precludes the administration or completion of the protocol treatment.
• Voluntary subjects having history or drugs and/or alcohol abuse.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, 110221, Colombia

Location

Study Officials

• Lilian Torregrosa Almonacid, MD

  Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, single arm, Phase 1 study. 24 participants are anticipated, assuming that 6 participants are recruited in each of the levels of dose titration based on the 3 +3 design.

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: September 10, 2018
• Study Start: April 30, 2019
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CO (1)