A Pharmacokinetic Study of a Botanical Extract

Information

  • Research Project
  • 6405564
  • ApplicationId
    6405564
  • Core Project Number
    R43AT000465
  • Full Project Number
    1R43AT000465-01A1
  • Serial Number
    465
  • FOA Number
  • Sub Project Id
  • Project Start Date
    9/17/2001 - 23 years ago
  • Project End Date
    8/31/2002 - 22 years ago
  • Program Officer Name
    KITT, CHERYL A.
  • Budget Start Date
    9/17/2001 - 23 years ago
  • Budget End Date
    8/31/2002 - 22 years ago
  • Fiscal Year
    2001
  • Support Year
    1
  • Suffix
    A1
  • Award Notice Date
    9/17/2001 - 23 years ago

A Pharmacokinetic Study of a Botanical Extract

DESCRIPTION (provided by applicant): A new approach is proposed for conducting pharmacokinetic studies of a pharmacologically active botanical extract containing mixtures of several classes of active and inactive compounds. We are currently developing the botanical extract as a botanical drug under an allowed Investigational New Drug (IND) by the FDA. We have identified key marker compounds for PK studies based on relevant biological activity and relative abundance in the extract. We propose to develop and validate a sensitive and accurate analytical method for quantitation of the marker compounds from plasma matrix in Phase I. Development of these methods will ultimately generate a robust approach for conducting routine GLP PK studies in animals and humans, which will be the subject of Phase II. The PK studies in human will provide new information, which will be used for NDA approval of the botanical drug as an effective treatment of insomnia, a condition with a large unmet medical need for effective and safe therapeutics with a low adverse effect profile. Successful completion of the long-range goals also will enable development of unique formulations and selection of dose regimen in elderly populations. PROPOSED COMMERCIAL APPLICATION: This project will support the development, under IND, of an important new class of drugs, the Botanical Drug Product. The botanical extract, which is the subject of this study, will be developed as an effective and safe new therapeutic for insomnia, a condition where currently 95% of those affected by the disease are not currently taking prescription medication. The botanical extract we will develop as a new drug has a favorable profile relative to the "ideal" drug for treatment of this condition.

IC Name
NATIONAL CENTER FOR COMPLEMENTARY &ALTERNATIVE MEDICINE
  • Activity
    R43
  • Administering IC
    AT
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    211751
  • Sub Project Total Cost
  • ARRA Funded
  • CFDA Code
    213
  • Ed Inst. Type
  • Funding ICs
    NCCAM:211751\
  • Funding Mechanism
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    ANCILE PHARMACEUTICALS, INC.
  • Organization Department
  • Organization DUNS
  • Organization City
    SAN DIEGO
  • Organization State
    CA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    92121
  • Organization District
    UNITED STATES