Pharmacokinetics Study of Antitumor B in Healthy Volunteers

Status unconfirmed

Conditions studied: Healthy Adults

In brief

The purpose of this study is to evaluate the single-dose oral pharmacokinetics of an herbal supplement - Antitumor B - in healthy subjects.

Key facts

Study ID

NCT04230057

Run by

University of Houston

People needed

12

Starts

2019-12-12

Expected to finish

2021-08-30

Last updated by the study team

2020-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A potential subject must meet all the following inclusion criteria to be eligible to participate in the study.
• Health questionnaire filled on the day of recruitment, after signing the written consent form
• Participants must receive administration of study agent within 21-28 calendar days of being selected as subject after screening procedure is completed
• Healthy male or female subjects aged ≥18 and ≤40 years of age
• Subjects must have a body mass index (BMI) between 18.0-29.9 kg/m² inclusive
• CBC/differential obtained within 14 calendar days prior to selection as subject for drug administration , with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb
• ≥ 8.0 g/dl is acceptable.);
• Adequate renal and hepatic function within 14 calendar days prior to selection as subject for drug administration defined as follows: Serum creatinine < 1.5 mg/dl or creatinine clearance (CCr) ≥ 50 ml/min within 14 calendar days prior to selection as subject for drug administration, determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)
• Total bilirubin < 2 x the institutional Upper limit of Normal range (ULN) within 14 calendar days prior to selection as subject for drug administration
• AST or ALT ≤ 3 x the institutional ULN within 14 calendar days prior to selection as subject for drug administration
• ALP or GGT ≤ 2.5 x the institutional ULN within 14 calendar days prior to selection as subject for drug administration
• Magnesium, calcium, glucose, potassium, and sodium within 14 calendar days prior to selection as subject for drug administration, with the following required parameters: Magnesium: > 0.9 mg/dl or < 3 mg/dl; Calcium: > 7 mg/dl or < 12.5 mg/dl; Glucose: > 40 mg/dl or < 250 mg/dl; Potassium: > 3 mmol/L or < 6 mmol/L; Sodium: > 130 mmol/L or < 155 mmol/L.
• Participant must have active health insurance coverage at the time of study
• Participants must be able to understand study-specific information and instructions in English.
• Participant must be willing to fully comply with study procedures and restrictions.
• Participant must be able to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any studyrelated procedures

You may not qualify if…

• History of active liver disease or cancer.
• Severe current or recurrent comorbidity such as (e.g., cardiovascular, haematological, neurological, endocrine, renal, liver, GI, HIV-AIDS, or other conditions such as cancer) that could affect the absorption and/or disposition of ATB
• Any disease/illness diagnosed by a licensed physician.
• Blood report positive for HIV and/or Hepatitis B and C tests
• Has had an acute illness within two weeks prior to screening.
• Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
• Concurrent use of any prescription medication (including medicinal botanical) except birth control pills, over the counter medication and supplements except Vitamins and mineral supplements, or herbal supplements in form of herbal mixtures, teas or individual compounds (such as querctein, curcumin, echinacea, flaxseed, ginseng, ginkgo, soy etc.) that the study PI believes could potentially impact the results/objectives of this study.
• Concurrent use of recreational drugs or alcohol during the study (self-declared by study participants)
• Prisoners
• Economically and/or educationally disadvantaged persons

Where it is running

• University of Houston, College of Pharmacy — Houston, Texas, United States

Full record on ClinicalTrials.gov

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