Pharmacokinetics Study of Antitumor B in Healthy Volunteers
NCT ID: NCT04230057
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
12 participants
OBSERVATIONAL
2019-12-12
2021-08-30
Brief Summary
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Detailed Description
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1. determine the saliva and plasma concentration of four key constituents of ATB (matrine, dictamnine, maackiain, fraxinellone) and
2. develop the in vivo correlation between plasma and saliva concentrations
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Antitumor B
Single dose 2400 mg
Interventions
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Antitumor B
Single dose 2400 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must receive administration of study agent within 21-28 calendar days of being selected as subject after screening procedure is completed
3. Healthy male or female subjects aged ≥18 and ≤40 years of age
4. Subjects must have a body mass index (BMI) between 18.0-29.9 kg/m² inclusive
5. 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.);
6. 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)
7. Total bilirubin \< 2 x the institutional Upper limit of Normal range (ULN) within 14 calendar days prior to selection as subject for drug administration
8. AST or ALT ≤ 3 x the institutional ULN within 14 calendar days prior to selection as subject for drug administration
9. ALP or GGT ≤ 2.5 x the institutional ULN within 14 calendar days prior to selection as subject for drug administration
10. 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.
11. Participant must have active health insurance coverage at the time of study
12. Participants must be able to understand study-specific information and instructions in English.
13. Participant must be willing to fully comply with study procedures and restrictions.
14. 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
Exclusion Criteria
2. 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
3. Any disease/illness diagnosed by a licensed physician.
4. Blood report positive for HIV and/or Hepatitis B and C tests
5. Has had an acute illness within two weeks prior to screening.
6. Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
7. 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.
8. Concurrent use of recreational drugs or alcohol during the study (self-declared by study participants)
9. Prisoners
10. Economically and/or educationally disadvantaged persons
18 Years
ALL
Yes
Sponsors
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University of Houston
OTHER
Responsible Party
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Ming Hu
Professor
Principal Investigators
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Ming Hu, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Houston
Locations
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University of Houston, College of Pharmacy
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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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
Other Identifiers
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STUDY00001235
Identifier Type: -
Identifier Source: org_study_id