A study to compare low-volume blood sampling techniques versus conventional blood collection from veins to evaluate drug concentration profiles after administration of a single dose of various study drugs in healthy subjects

An open-label, parallel-group study to compare low-volume blood sampling techniques versus conventional venipuncture for the assessment of pharmacokinetic profiles of a single dose of various study drugs in healthy subjects

  • Healthy Volunteers
Trial Status:

Recruiting

This trial runs in
Countries
  • United States
Trial Identifier:

GE43429

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      The source of the below information is the publicly available website ISRCTN.com. It has been summarised and edited into simpler language.

      The below information is sourced from the publicly available website ISRCTN.com and has not been edited.

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      Trial Summary

      The aim of this study is to test and compare different methods of collecting blood to see how the methods differ with regard to determining how a participant's body processes a single dose of study drug (how the study drug is absorbed, distributed, broken down, and removed by one’s body). The following collection methods will be studied:

      1. Venipuncture: blood is drawn through a needle inserted into the participant’s arm (the current standard for blood sampling).
      2. TASSO OnDemand: this device sticks to the skin with a light adhesive. When the button is pressed, a vacuum forms and a lancet pricks the surface of the skin. The vacuum draws blood out of participants’ capillaries (blood-containing structures) and into a tube attached to the bottom of the device.
      3. Neoteryx Mitra: this device collects a very small amount of blood on two sponge tips after a separate skin prick using a lancet.
      F. Hoffmann-La Roche Ltd (USA) Sponsor
      Phase I Phase
      GE43429 Trial Identifier
      Both Gender
      Adult Age
      Yes Healthy Volunteers

      Who can participate?
      People aged between 18 to 65 years who are healthy

      What does the study involve?
      This study has three parts:

      1. Screening (to see if people are eligible for the study)
      2. Check-in and treatment
      3. Follow-up (to check after treatment is finished)

      During this study, there will be up to nine visits. The first visit may last 3 days and later visits may last 3 hours. The total time in the study will be up to about 4.5 months.

      What are the possible benefits and risks of participating?
      Participants will not receive any benefit from participating in this study but the information that is learned may help patients with certain diseases or conditions in clinical trials in the future.

      There may be side effects from the drug or procedures used in this study, which can be mild to severe and even life-threatening, and they can vary from person to person. The study doctor will assess right away if participants have any of the following during the study:

      1. Symptoms that are new or have worsened
      2. Changes in prescribed or over-the-counter medications (including herbal therapies)
      3. Visits to the doctor or hospital, including urgent care or emergency room visits

      There may be a risk in exposing an unborn child to the study drug and all risks are not known at this time. Women and men must take precautions to avoid exposing an unborn child to the study drug. If participants are pregnant, become pregnant, or are currently breastfeeding, one cannot take part in this study. As is true for any experimental drug, there may be unknown and potentially serious or life-threatening side effects, infusion-related injuries or death. These adverse events (side effects) listed in the table below were reported in previous studies from patients who received more than one dose of the study drug.

      Crenezumab is an experimental drug that is being studied as a potential treatment for patients with Alzheimer’s disease, a brain disease that causes problems with memory, behavior, and thinking ability. Subjects may experience side effects from the drug or procedures in this study. Side effects can vary from mild to very serious and may be different from person to person. The majority of side effects identified in studies are from observations following dosing over an extended period and are not likely to occur with administration of only one dose of crenezumab. Risks associated with crenezumab include allergic reactions such as itching, difficulty breathing, rash and/or drop in blood pressure; pneumonia, local reactions at site of infusion/injection. There is also a rare risk of death.

      Giredestrant is still being studied, and the side effect profile is not completely known. So far, the known side effects appear to be mild to moderate in severity with no known serious risks. The vast majority of these side effects resolved without the need for treatment or interruption of giredestrant. It is also possible that subjects might experience side effects that are unknown at this time. As is true for any experimental drug, there may be unknown and potentially serious or life-threatening side effects, including death, that could occur with giredestrant. However, the majority of side effects identified in studies are from observations following dosing over an extended period and are not likely to occur with only one dose of giredestrant. Common side effects observed with giredestrant include joint pain, diarrhea, dizziness, fatigue, muscle and/or bone pain, nausea, hot flushes and vomiting.

      Etrolizumab is still being studied, and the side effect profile is not completely known. The majority of side effects identified in studies are from observations following dosing over an extended period and are not likely to occur with only one dose of etrolizumab. The very common side effects include joint ache, fatigue, rash, common cold and uncommon side effects are skin inflammation, rash with the presence of flat discolored area, appendicitis.

      Hydroxychloroquine has well-established safety profiles, as it has been marketed for over 60 years for the treatment of malaria, rheumatoid arthritis, and systemic lupus erythematosus. While most of the side effects reported are for more than one dose of hydroxychloroquine, as a healthy volunteer who is receiving a single dose of the drug, patients may or may not experience some of these common side effects: Nausea, vomiting, stomach pain or cramps, loss of appetite, weight loss, diarrhea, dizziness, spinning sensation, headaches, ringing in the ears, mood changes, nervousness, irritability, skin rash, itching, hair loss and blurred vision.

      Where is the study run from?
      F. Hoffmann-La Roche Ltd (USA)

      When is the study starting and how long is it expected to run for?
      June 2021 to May 2022

      Who is funding the study?
      F. Hoffmann-La Roche Ltd (USA)

      Who is the main contact?
      Trial Information Support Line (TISL)
      global-roche-genentech-trials@gene.com

      Trial Summary

      The aim of this study is to test and compare different methods of collecting blood to see how the methods differ with regard to determining how a participant's body processes a single dose of study drug (how the study drug is absorbed, distributed, broken down, and removed by one’s body). The following collection methods will be studied:

      1. Venipuncture: blood is drawn through a needle inserted into the participant’s arm (the current standard for blood sampling).
      2. TASSO OnDemand: this device sticks to the skin with a light adhesive. When the button is pressed, a vacuum forms and a lancet pricks the surface of the skin. The vacuum draws blood out of participants’ capillaries (blood-containing structures) and into a tube attached to the bottom of the device.
      3. Neoteryx Mitra: this device collects a very small amount of blood on two sponge tips after a separate skin prick using a lancet.
      F. Hoffmann-La Roche Ltd (USA) Sponsor
      Phase I Phase
      GE43429 Trial Identifier
      Crenezumab, etrolizumab, giredestrant, hydroxychloroquine Treatments
      Blood sampling techniques Condition
      Official Title

      An open-label, parallel-group study to compare low-volume blood sampling techniques versus conventional venipuncture for the assessment of pharmacokinetic profiles of a single dose of various study drugs in healthy subjects

      Eligibility Criteria

      Both Gender
      Adult Age
      Yes Healthy Volunteers

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