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What happens to a medicine (pralsetinib) when given to people with unhealthy livers
A I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Pralsetinib in Subjects With Moderate or Severe Hepatic Impairment Compared to Healthy Subjects
Metabolic Disorder Hepatic Insufficiency Failure
Basic Details
Male and Female
18 to 74 Years
Yes
Sponsor
Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)
Phase
Phase 1
Study Identifier
GP43163
Twenty-nine men and women were enrolled at four study sites in the USA to find out how pralsetinib behaved in the body. The main finding was a comparison of pralsetinib levels in groups of people with healthy liver function versus those with liver disease. Information from this study may be used to guide other studies with more people or to help doctors give the medicine safely to people with liver disease.
Who can participate?
Subjects aged between 18 to 74 years who are healthy, or have liver impairment.
What does the study involve? (what interventions will be compared, will all participants receive the same treatment, what measurements will be taken)
During this study, participants have two visits, including a screening visit up to 34 days before the start of the study, and a stay in the study site lasting 10 days and 9 nights. The total duration of participation in the study will be about 10 days. In this study, the study doctor, and the sponsor will know the drugs and the doses that are given. Participants will be given a single oral (by mouth) dose of 200 mg pralsetinib given as 2 capsules on Day 1 given in the morning with one cup of water after an overnight fast (no food or drink other than water) of at least 8 hours. Then, it will be required to remain fasting for at least 2 hours after dosing (a total fast of at least 10 hours). One will not be allowed to drink water (except for the water given with dosing) from 1 hour before dosing to 2 hours after taking the capsules.
This study requires that a blood sample be obtained that may be used for additional research involving genetic analysis of blood. If participants do not wish to have this sample collected, will not be permitted to participate in this study. There is an additional research that may involve long‑term storage for future analysis of blood for the Research Biosample Repository (RBR). Participants will be asked to sign a separate section of the informed consent for this additional research. If participants do not wish to participate in this additional research, the participation in this main research study will not be affected.
What are the possible benefits and risks of participating?
Participation in this study is purely for research purposes, and will not improve ones health or treat any medical problems. One may benefit by having physical examinations. The results of laboratory tests done at the screening visit will be made available upon request. However, if disqualified for study participation by other screening procedures, some laboratory tests may not be conducted.
Participants may have side effects from the drugs or procedures used in this study. Side effects can be mild to severe and even life threatening or fatal, and they can vary from person to person. Talk to the study doctor right away if one experiences any side effects during the study. There may be a risk in exposing an unborn child to study drug, and all risks are not known at this time. Women and men must take precautions to avoid exposing an unborn child to study drug, as described in Section 1.6. If participants are pregnant, become pregnant, or are currently breastfeeding, one cannot take part in this study.
Where is the study run from?
United States
When is the study starting and how long is it expected to run for?
November 2021 to June 2022
Who is funding the study?
Genentech, Inc
Who is the main contact?
global-roche-genentech-trials@gene.com
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 study 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 information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
What you can do next
To find this study again later, copy and save the study number:
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To see if this study is a good fit, talk to your doctor or nurse you trust.
Together, you can look at the For Medical Professional tab and look into your medical history.
Some medical centers in this study offer a contact line. Click "Find participating medical centers" in the map below.
For the latest version of this information please go to www.forpatients.roche.com