A Study of TAK-279 in Adults With or Without Liver Damage

Completed · Phase 1

Conditions studied: Hepatic Impairment, Healthy Volunteers

In brief

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.

Key facts

Study ID: NCT05976321
Run by: Takeda
People needed: 27
Starts: 2023-09-22
Expected to finish: 2024-04-15
Last updated by the study team: 2024-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

A. Participants with Hepatic Impairment:
The participants must fulfill the following inclusion criteria to be eligible for participation in the study (participants who do not qualify based on a reversible condition or mild intercurrent illness may be re-screened after the condition is resolved. Screening tests may be repeated if in the Investigator's opinion the test needs to be repeated):
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:
Supine blood pressure (BP) is ≥90/40 millimeters of mercury (mmHg) and ≤150/95 mmHg, at screening.
Supine pulse rate (PR) is ≥40 beats per minute (bpm) and ≤99 bpm, at screening.
Estimated creatinine clearance (CrCl) ≥60 millilitres per minute (mL/min) (using Cockcroft-Gault formula) at screening. Both estimated CrCl and estimated glomerular filtration rate (eGFR) using modification of diet in renal disease (MDRD) formula will be reported.
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:
Severe HI cohort, Child-Pugh Class C: ≥10 and ≤15.
Moderate HI cohort, Child-Pugh Class B: ≥7 and ≤9.
Mild HI cohort, Child-Pugh Class A: ≥5 and ≤6.
Female participants of childbearing potential agree to comply with any acceptable contraceptive requirements of the protocol.
B. Healthy Participants:
Understands the study procedures in the ICF and be willing and able to comply with the protocol.
Adult male or female participant aged ≥18 years, at screening. Participant will be matched to a participant with HI by age (±10 years) and sex.
Has a body weight greater than 50 kg and has a BMI ≥18.0 and ≤42.0 kg/m\^2, at screening. Participant will be matched a participant with HI by body weight (±15 kg).
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.
Medically healthy with no clinically significant medical history, physical examination, vital signs, or screening clinical laboratory profiles, as deemed by the Investigator or designee, including:
Supine BP is ≥90/40 mmHg and ≤150/95 mmHg, at screening.
Supine PR is ≥40 bpm and ≤99 bpm, at screening.
Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and total bilirubin (TBILI) within the upper limit of normal (ULN) at screening and at check-in.

You may not qualify if…

A. Participants with Hepatic Impairment:
The participant must be excluded from participating in the study if the participant:
Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
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:
Active infection or febrile illness within 7 days prior to dosing, as assessed by the Investigator or designee.
Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to dosing.
Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis).
An infected joint prosthesis unless that prosthesis has been removed or replaced within 60 days prior to dosing.
Opportunistic infections (e.g., Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
Cancer or lymphoproliferative disease within 5 years prior to dosing, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is not exclusionary.
Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
Liver or other solid organ transplant.
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.
Has positive results for the urine or saliva drug screen at screening or check-in, unless the positive drug screen is due to prescription drug use that is approved by the Investigator or designee and Sponsor.
Has positive results for urine or breath alcohol screen at screening or check-in.
Unable to refrain from or anticipates the use of any medication or substance (including prescription or over-the-counter, vitamin supplements, natural or herbal supplements).
Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study.
Has made a donation of blood or had significant blood loss within 56 days prior to dosing.
Has made a plasma donation within 7 days prior to dosing.
Participated in another clinical study within 30 days prior to dosing. The 30-day window will be derived from the date of the last dosing in the previous study to Day 1 of the current study.

Where it is running

University of Miami — Miami, Florida, United States
Orlando Clinical Research Center — Orlando, Florida, United States
American Research Corporation - Texas Liver Institute — San Antonio, Texas, United States
Pinnacle Clinical Research - San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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