A Study of TAK-279 in Adults With or Without Liver Damage (NCT05976321) | Clinical Trial Compass
CompletedPhase 1
A Study of TAK-279 in Adults With or Without Liver Damage
United States27 participantsStarted 2023-09-22
Plain-language summary
The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279.
The participants will need to stay at the clinic for 11 days.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
✓. Adult male or female participant aged ≥18 years, at screening.
✓. Has a body weight greater than 50 kilograms (kg) and has a body mass index (BMI) ≥18.0 and ≤42.0 kilograms per meter square (kg/m\^2), at screening.
✓. Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent \[including electronic cigarettes\]) before screening. Participant must agree to smoke no more than 5 cigarettes or equivalent/day (including electronic cigarettes) from the 7 days prior to TAK-279 dosing.
✓. Aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, or screening clinical laboratory profiles, as deemed by the Investigator or designee, including:
✓. Have had chronic HI for at least 3 months before screening, and the HI must be stable, i.e., no significant changes in hepatic function in the 30 days preceding screening (or since the last visit if within 3 months before screening).
✓. Has a score on the Child-Pugh Class at screening as follows:
✓. Female participants of childbearing potential agree to comply with any acceptable contraceptive requirements of the protocol.
Exclusion criteria
✕. Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
What they're measuring
1
Cmax: Maximum Observed Plasma Concentration for TAK-279
Timeframe: Predose and at multiple time points post dose from Days 1 to 10
2
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
Timeframe: Predose and at multiple time points post dose from Days 1 to 10
3
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
Timeframe: Predose and at multiple time points post dose from Days 1 to 10
. Has history or presence of clinically significant medical or psychiatric condition or disease (aside from HI) in the opinion of the Investigator or designee.
✕. Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
✕. Has a history of any of the following:
✕. Has history or presence of alcoholism and/or drug abuse within the past 6 months prior to dosing, as determined by the Investigator or designee.
✕. Has history or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
✕. Female with a positive pregnancy test or who is lactating.
✕. Has electrocardiogram (ECG) abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the Investigator or designee.