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Fatty Acid Synthase Inhibitor
TVB-2640 50 mg - normal hepatic function for Liver Disease
Phase 1
Waitlist Available
Research Sponsored by Sagimet Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to day 7
Awards & highlights
Study Summary
This trial will test how safe and tolerated a drug is for people with liver problems, compared to those with healthy livers.
Eligible Conditions
- Liver Disease
- Liver Cirrhosis
- Non-alcoholic Fatty Liver Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening to day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to day 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum plasma concentration (Cmax) for total TVB-2640 at steady state
Maximum plasma concentration (Cmax) for unbound TVB-2640 at steady state
Total TVB-2640 plasma concentration-time (AUC) at steady state
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: TVB-2640 50 mg - severe hepatic functionExperimental Treatment1 Intervention
Subjects with severe hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4
Group II: TVB-2640 50 mg - normal hepatic functionExperimental Treatment1 Intervention
Healthy subjects with normal hepatic function receive 50 mg PO daily from Day 1 to Day 4
Group III: TVB-2640 50 mg - moderate hepatic functionExperimental Treatment1 Intervention
Subjects with moderate hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4
Group IV: TVB-2640 50 mg - mild hepatic functionExperimental Treatment1 Intervention
Subjects with mild hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TVB-2640 - 50 mg
2023
Completed Phase 1
~50
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Sagimet Biosciences Inc.Lead Sponsor
7 Previous Clinical Trials
568 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a heart condition called ventricular dysfunction or have a history of factors that can cause a dangerous heart rhythm called Torsade de Pointes. You will also be excluded if anyone in your family has a condition called long QT syndrome that affects the heart's electrical activity.You are taking or planning to take any medications or products that can affect how the study drug is absorbed, processed, or removed from your body.You drink more than 21 units of alcohol per week if you're a male, or more than 14 units if you're a female.People with diabetes can join the study if they have:You have had past eye problems like swollen cornea, eye inflammation, or dry eyes. You can wear contact lenses during the study except on the days you receive the medication.You have a history of or currently have a serious medical condition affecting your metabolism, allergies, skin, kidneys, blood, lungs, heart, stomach, brain, breathing, hormones, or mental health, as determined by the doctor in charge of the study.
Research Study Groups:
This trial has the following groups:- Group 1: TVB-2640 50 mg - normal hepatic function
- Group 2: TVB-2640 50 mg - mild hepatic function
- Group 3: TVB-2640 50 mg - moderate hepatic function
- Group 4: TVB-2640 50 mg - severe hepatic function
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Liver Disease Patient Testimony for trial: Trial Name: NCT05835180 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Group 1 earned FDA authorization?
"Given the preliminary nature of this Phase 1 trial, we have assigned Group 1 a safety rating of '1', as there is restricted data regarding its efficacy and hazard profile."
Answered by AI
Can I be admitted as a participant in this research?
"Aspiring participants for this research must have non-alcoholic fatty liver disease and lie within the age bracket of 18 to 75. 48 individuals are needed for the study's completion."
Answered by AI
Does the age of 55+ disqualify individuals from taking part in this investigation?
"To participate in this trial, individuals must be of age between eighteen and seventy-five. For those under the legal age or over sixty-five, there are 102 studies and 699 studies respectively."
Answered by AI
Is this experiment still enrolling participants?
"Data from clinicaltrials.gov reveals that this medical study is not currently enrolling any new patients, though it was initially posted on April 21st 2023 and last updated on the 17th of the same month. Nevertheless, there are still 783 other trials out there actively recruiting participants now."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Eric J. Lawitz, MD
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
My Dad died of liver cancer, I don't want to.
PatientReceived 1 prior treatment
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