A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants

  • Neurodegenerative Disorder
  • Alzheimer's Disease (AD)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

NCT04394845 GN42043

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      The purpose of this study is to evaluate the biodistribution, safety and tolerability of a single dose of [18F]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese participants.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT04394845, GN42043 Trial Identifier
      [18F]GTP1 Treatments
      Alzheimer Disease Condition
      Official Title

      Assessment of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Subjects

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Healthy with no clinically relevant finding on physical examination at screening and prior to radiopharmaceutical administration
      • Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 30 days after the final dose
      • Male participants with partners of childbearing potential must commit to the use of two methods of contraception for the study duration and 90 days after the last dose
      • Male participants must not donate sperm for the duration of the study and 90 days after the last dose
      • Participants must have both Japanese parents and all Japanese grandparents
      Exclusion Criteria
      • Participants with any significant medical disorder or disease expected to interfere with the study
      • Current or prior history (within a six-month period) of exposure to nicotine products
      • History of drug or alcohol abuse within 12 months prior to screening
      • Prior participation in other research protocols or clinical care in the last year, such that radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSv), the allowable annual limit for research participants as established by the US Federal Guidelines
      • Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing
      • Use of over the counter (OTC) medication, dietary supplements, or vitamins, within 2 weeks prior to initial dosing
      • Known hypersensitivity to any component of the formulation of [18F]GTP1 or related compounds
      • Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing
      • History of immunodeficiency diseases, including positive human immunodeficiency virus (HIV) test
      • Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody
      • Women who are pregnant, lactating or breastfeeding
      • Unsuitable veins for repeated venipuncture

      For the latest version of this information please go to www.forpatients.roche.com

       

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