Pharmacokinetics Study of Antitumor B in Healthy Volunteers

NCT04230057 | Unknown

• 1 other identifier: STUDY00001235
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adults

Keywords

Pharmacokinetics; Antitumor B; healthy volunteer

Outcome Measures

Primary Outcomes (6)

• Cmax of matrine, dictamnine, maackiain and fraxinellone in plasma

  Maximum (peak) observed drug concentration in plasma

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose

• Cmax of matrine, dictamnine, maackiain and fraxinellone in saliva

  Maximum (peak) observed drug concentration in saiva

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose

• Tmax of matrine, dictamnine, maackiain and fraxinellone in plasma

  Time of Maximum (peak) observed drug concentration in plasma

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose

• Tmax of matrine, dictamnine, maackiain and fraxinellone in saliva

  Time of Maximum (peak) observed drug concentration in saliva

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose

• AUC0-24 of matrine, dictamnine, maackiain and fraxinellone in plasma

  Area under the curve of plasma concentration-time profile

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose

• AUC0-24 of matrine, dictamnine, maackiain and fraxinellone in saliva

  Area under the curve of saliva concentration-time profile

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose

Secondary Outcomes (1)

• Plasma-saliva IVIVC

  Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose

Study Arms (1)

Healthy volunteer

* In good general health and feeling well (no diagnosed disorders/illnesses) * At least 18 years old * BMI in the range of 18-29.9 kg/m² * No known history of substance abuse * No known allergies to food/drug

Dietary Supplement: Antitumor B

Interventions

Antitumor B DIETARY_SUPPLEMENT

Single dose 2400 mg

Also known as: Zeng Sheng Ping, ACAPHA, ATB

Healthy volunteer

Eligibility Criteria

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

Study Population

Healthy subjects in University of Houston and nearby area

You may qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

University of Houston, College of Pharmacy

Houston, Texas, 77204, United States

Location

Related Publications (9)

• Lin PZ, Zhang JS, Cao SG, Rong ZP, Gao RQ, Han R, Shu SP. [Secondary prevention of esophageal cancer--intervention on precancerous lesions of the esophagus]. Zhonghua Zhong Liu Za Zhi. 1988 May;10(3):161-6. Chinese.

  PMID: 3219974 BACKGROUND

• Lin P, Zhang J, Rong Z, Han R, Xu S, Gao R, Ding Z, Wang J, Feng H, Cao S. Studies on medicamentous inhibitory therapy for esophageal precancerous lesions--3- and 5-year inhibitory effects of antitumor-B, retinamide and riboflavin. Proc Chin Acad Med Sci Peking Union Med Coll. 1990;5(3):121-9.

  PMID: 2098764 BACKGROUND

• Lin P. [Medicamentous inhibitory therapy of precancerous lesions of the esophagus--3 and 5 year inhibitory effect of antitumor B, retinamide and riboflavin]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 1990 Aug;12(4):235-45. Chinese.

  PMID: 2147582 BACKGROUND

• Sun Z, Guan X, Li N, Liu X, Chen X. Chemoprevention of oral cancer in animal models, and effect on leukoplakias in human patients with ZengShengPing, a mixture of medicinal herbs. Oral Oncol. 2010 Feb;46(2):105-10. doi: 10.1016/j.oraloncology.2009.06.004. Epub 2009 Dec 21.

  PMID: 20022553 BACKGROUND

• Zhang Z, Wang Y, Yao R, Li J, Yan Y, La Regina M, Lemon WL, Grubbs CJ, Lubet RA, You M. Cancer chemopreventive activity of a mixture of Chinese herbs (antitumor B) in mouse lung tumor models. Oncogene. 2004 May 6;23(21):3841-50. doi: 10.1038/sj.onc.1207496.

  PMID: 15021904 BACKGROUND

• Wang Y, Yao R, Gao S, Wen W, Du Y, Szabo E, Hu M, Lubet RA, You M. Chemopreventive effect of a mixture of Chinese Herbs (antitumor B) on chemically induced oral carcinogenesis. Mol Carcinog. 2013 Jan;52(1):49-56. doi: 10.1002/mc.20877. Epub 2011 Nov 15.

  PMID: 22086836 BACKGROUND

• Yin T, Yang G, Ma Y, Xu B, Hu M, You M, Gao S. Developing an activity and absorption-based quality control platform for Chinese traditional medicine: Application to Zeng-Sheng-Ping(Antitumor B). J Ethnopharmacol. 2015 Aug 22;172:195-201. doi: 10.1016/j.jep.2015.06.019. Epub 2015 Jun 20.

  PMID: 26099633 BACKGROUND

• Gao S, Yang Z, Yin T, You M, Hu M. Validated LC-MS/MS method for the determination of maackiain and its sulfate and glucuronide in blood: application to pharmacokinetic and disposition studies. J Pharm Biomed Anal. 2011 May 15;55(2):288-93. doi: 10.1016/j.jpba.2011.01.015. Epub 2011 Jan 22.

  PMID: 21349678 BACKGROUND

• Yang Z, Gao S, Yin T, Kulkarni KH, Teng Y, You M, Hu M. Biopharmaceutical and pharmacokinetic characterization of matrine as determined by a sensitive and robust UPLC-MS/MS method. J Pharm Biomed Anal. 2010 Apr 6;51(5):1120-7. doi: 10.1016/j.jpba.2009.11.020. Epub 2009 Nov 26.

  PMID: 20034755 BACKGROUND

Related Links

• Standardization and Clinical Testing of ACAPHA for Cancer Prevention Part 1 of 3
• Standardization and Clinical Testing of ACAPHA for Cancer Prevention Part 2 of 3
• Standardization and Clinical Testing of ACAPHA for Cancer Prevention Part 3 of 3
• ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Saliva

MeSH Terms

Interventions

Antitumor B; antitumor A

Study Officials

• Ming Hu, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2020
• First Posted: January 18, 2020
• Study Start: December 12, 2019
• Primary Completion: January 21, 2020
• Study Completion: August 30, 2021
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

US (1)