A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide. During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).

Key facts

Study ID

NCT06290050

Run by

Takeda

People needed

20

Starts

2024-03-29

Expected to finish

2024-05-16

Last updated by the study team

2024-05-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must fulfill all of the following inclusion criteria to be eligible for participation in the study:
• Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
• Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilogram per square meter (kg/m\^2) at the screening visit.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the investigator or designee, including the following:
• Seated blood pressure (BP) is >=90/40 millimeter of mercury (mmHg) and <=140/90 mmHg at the screening visit.
• Seated pulse rate (PR) is >=40 beats per minute (bpm) and <=99 bpm at the screening visit.
• ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit.
• Estimated glomerular filtration rate (eGFR) >=80 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) at the screening visit.
• Liver function tests including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin <= ULN at the screening visit and at check-in.

You may not qualify if…

• Participants must not be enrolled in the study if they meet any of the following criteria:
• Fasting glucose >125 milligram per deciliter (mg/dL) at the screening visit.
• Has a history or presence of any of the following:
• Active infection or febrile illness within 7 days prior to first dosing, as assessed by the investigator or designee.
• Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to first 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 greater than 60 days prior to first dosing.
• Opportunistic infections (example, Pneumocystis jirovecii pneumonia, histoplasmosis, Coccidiomycosis) exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is not exclusionary.
• Cancer or lymphoproliferative disease within 5 years prior to first 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.
• Solid organ transplant.
• Diabetes or prior episode(s) of hypoglycemia.
• Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to first dosing, as determined by the investigator or designee.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs.
• History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (example, heart failure, cardiomyopathy, family history of Long QT Syndrome).
• Positive urine drug or alcohol results at the screening visit or check-in.
• Unable to refrain from or anticipates the use of:
• Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements including any CYP3A4 and CYP2C8 inhibitors, beginning 14 days prior to the first dosing.
• Any drugs known to be inducers of CYP3A4 and CYP2C8 enzymes and/or P-gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (example, Flockhart Table™) including the product label for midazolam and repaglinide will be consulted to confirm lack of PK/pharmacodynamic interaction with the study drugs.
• Has made a donation of blood or had significant blood loss within 56 days prior to first dosing.
• Has made a plasma donation within 7 days prior to first dosing.
• Participated in another clinical study within 30 days prior to first dosing. The 30 day window will be derived from the date of the last dosing in the previous study to Day 1 of Period 1 of the current study.
• Herpes infections:
• Has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at the screening visit or Day 1 of Period 1.
• Has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.