A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

The main aim of this study is to find out how the body of a healthy adult processes TAK-279 (pharmacokinetics) when substances that either hinder or help the human metabolism such as erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn about side effects and how well it is tolerated when TAK-279 is given alone and together with substances that impact human metabolism. The participants will need to stay at the clinic for up to 26 days.

Key facts

Study ID

NCT05995249

Run by

Takeda

People needed

172

Starts

2023-08-11

Expected to finish

2023-12-31

Last updated by the study team

2024-02-06

Who can join

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

You may qualify if…

• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
• Healthy, adult, male or female of non-childbearing potential, 18-55 years of age, inclusive, at the screening visit.
• Male participants must follow protocol specified contraception guidance.
• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 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 is ≥ 40 beats per minute (bpm) and ≤ 99 bpm at the screening visit.
• Part 1 only: QTcF interval is ≤ 450 msec (males and females) and has ECG findings considered normal or not clinically significant by the Investigator or designee at the screening visit.
• Part 2 and 3: ECG findings considered normal or not clinically significant by the Investigator or designee at the screening visit.
• Estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73m\^2 at the screening visit.
• Liver function tests including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin ≤ upper limit of normal (ULN) at the screening visit and at check-in.
• No clinically significant hypokalemia or hypomagnesemia at the screening visit.

You may not qualify if…

• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
• 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 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 (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
• 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.
• Liver or other solid organ transplant.
• 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, including macrolide antibiotics (Part 1 only; eg, erythromycin) or anti-seizure agents (Part 2 only; eg, phenytoin) or anti-viral drugs (Part 3 only; eg, efavirenz).
• Part 2 and Part 3 only: Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) or has a risk of suicide according to the Investigator's or designee judgment based on the assessment of the C-SSRS at the screening visit or check-in or has made a suicide attempt within 12 months before the first dosing.
• Part 2 only: History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the Investigator or designee considers to be clinically significant.
• Part 2 only: Participant is known to be a CYP2C9 and/or CYP2C19 poor metabolizer based on genotyping prior to screening or is determined to be a CYP2C9 and/or CYP2C19 poor metabolizer at the screening visit.
• History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (eg, heart failure, cardiomyopathy, family history of Long QT Syndrome).
• Female participant of childbearing potential.
• Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating.
• 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 beginning 14 days prior to the first dosing.
• Any drugs known to be moderate or strong inducers of CYP3A4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (eg, Flockhart Table™) including the product label for erythromycin (Erythromycin Tablets USP 2018), phenytoin (DILANTIN (extended phenytoin sodium capsules) 2022), and efavirenz (SUSTIVA (efavirenz) capsules and tablets 2019) will be consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamic interaction with the study drugs.
• 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 first dosing and throughout the study.

Where it is running

• Celerion - Tempe, AZ Site — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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