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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 predose and at multiple time points post dose from days 1 to 10
Awards & highlights
Study Summary
This trial looks at how TAK-279 affects people with & without liver issues & checks for side effects & how well it's tolerated. Participants must stay at clinic for 11 days.
Who is the study for?
This trial is for adults over 18 with stable liver disease (Child-Pugh Class A, B, or C) and healthy adults matched by age and weight. Participants must understand the study, be willing to follow its rules, have a BMI of 18-42 kg/m^2, smoke moderately or not at all, and women must agree to use contraception.Check my eligibility
What is being tested?
The study tests how TAK-279 is processed in people with different levels of liver health compared to those without liver issues. It also looks at side effects and tolerance after one dose. Participants will stay in the clinic for 11 days during the trial.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to TAK-279 which could range from mild symptoms like headaches or nausea to more serious ones depending on individual responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose and at multiple time points post dose from days 1 to 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and at multiple time points post dose from days 1 to 10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
Cmax: Maximum Observed Plasma Concentration for TAK-279
Secondary outcome measures
AUClast,u: Area Under the Unbound Drug Concentration-time Curve, From Time 0 to the Last Quantifiable Concentration of TAK-279
AUC∞,u: Area Under the Unbound Drug Concentration-time Curve, From Time 0 to Infinity of TAK-279
Cmax,u: Maximum Observed Unbound TAK-279 Plasma Concentration
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3, Mild/Severe HI: TAK-279 50 mgExperimental Treatment1 Intervention
Participants with mild/severe HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study based on an evaluation of the results from Part A.
Group II: Cohort 2, Normal Hepatic Function: TAK-279 50 mgExperimental Treatment1 Intervention
Participants with normal hepatic function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. Based on an evaluation of the results from Part A, additional participants with normal hepatic function may be enrolled in Part B of the study.
Group III: Cohort 1, Moderate HI: TAK-279 50 mgExperimental Treatment1 Intervention
Participants with moderate HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-279
2023
Completed Phase 1
~180
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,912 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,240 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to follow the birth control requirements.My kidneys are working well, with a creatinine clearance rate of 60 mL/min or more.I do not have active herpes, other viral diseases, or tuberculosis.I smoke 10 or fewer cigarettes a day and will cut down to 5 or fewer a week before starting the medication.I have liver issues but am healthy enough for the study based on recent exams.I do not have severe liver problems, mental incapacity, significant emotional issues, or specific medical conditions.I have had stable liver inflammation for at least 3 months.I have had liver problems for at least 3 months with stable liver function.My liver function score is within the required range.My liver function is slightly impaired, scoring 5 to 6 on the Child-Pugh scale.I am an adult over 18, weigh more than 50 kg, have a BMI between 18 and 42, and I don't smoke much or at all.I am healthy with no significant medical issues.My kidney function is good, with a filtration rate of 60 mL/min or higher.I am mentally and legally capable, without significant emotional problems or disqualifying medical conditions.I do not have active herpes, other viral diseases, or tuberculosis with my liver condition.I am over 18, weigh more than 50 kg, have a BMI between 18 and 42, and I don't smoke or only smoke moderately.I do not have liver problems combined with infections, cancer history, weak immunity, organ transplants, alcohol/drug abuse, allergies, pregnancy, heart issues, or recent substance use or blood donations.I am 18 years old or older.I weigh more than 50 kg and my BMI is between 18.0 and 42.0.My liver function is severely impaired, classified as Child-Pugh C.My liver function is moderately impaired.I have liver problems.I am 18 years or older and will be matched with a participant of similar age and sex.My weight is over 50 kg, and my BMI is between 18.0 and 42.0.I agree to follow the study's birth control requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1, Moderate HI: TAK-279 50 mg
- Group 2: Cohort 2, Normal Hepatic Function: TAK-279 50 mg
- Group 3: Cohort 3, Mild/Severe HI: TAK-279 50 mg
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are associated with the intake of Cohort 1, Moderate HI: TAK-279 50 mg?
"Cohort 1, Moderate HI: TAK-279 50 mg has not been thoroughly studied yet and thus receives a score of 1 due to limited data that supports its safety or efficacy."
Answered by AI
Is this trial currently recruiting participants?
"Unfortunately, this clinical trial has ceased its recruitment process according to the data on clinicialtrials.gov. Initially posted August 23rd 2023 and last updated July 28th 20203, there are currently 1053 other trials actively welcoming patient enrolment instead."
Answered by AI
Who else is applying?
What site did they apply to?
American Research Corporation - Texas Liver Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
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