Phase 1 Study on Mass Balance, Pharmacokinetics, and Metabolism of Oral [14C]-Zipalertinib in Healthy Adult Male Subjects with Cancer

Trial ID: 2023-505085-28-00
Protocol: TAS6417-102
Sponsor: Taiho Oncology Inc.

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Diseases & Conditions

Non-small cell lung cancer

Objectives

The primary objective of this Phase 1 study is to evaluate the **mass balance**, pharmacokinetics, and metabolism of oral [14C]-zipalertinib in healthy adult male subjects. This investigation is clinically relevant as it aims to understand the absorption, distribution, metabolism, and excretion (ADME) profile of zipalertinib, which is crucial for determining its safety and efficacy in future therapeutic applications for **cancer** treatment.

Participants

The clinical trial focuses on **cancer** and involves a study population exclusively comprising male participants. The age range of the participants spans from adults to the elderly, specifically categorized within the age groups of 18-64 and 65 years and older. The trial does not include a vulnerable population, and the selection criteria for the trial population have not been disclosed by the sponsor. Additionally, no information regarding the total number of participants, their general health status, or lifestyle considerations such as diet, physical activity, or habits has been provided. The sponsor has not given any further details on key inclusion or exclusion criteria.

Plans and Procedures

The clinical trial is designed as a **Phase 1** study to evaluate the mass balance, pharmacokinetics, and metabolism of oral [14C]-zipalertinib in healthy adult male subjects. The trial employs a **randomized**, **double-blind**, and **controlled** methodology to ensure the reliability and validity of the results. The estimated duration of the trial spans from July 5, 2023, to August 22, 2023, encompassing a comprehensive timeline for participant involvement and data collection.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit is crucial for ensuring that only suitable candidates are enrolled in the study. Following the screening, participants will attend scheduled follow-up visits, which are structured to monitor the pharmacokinetic and metabolic responses to the investigational product. These visits are essential for collecting data on the drug's behavior in the body and its potential therapeutic effects. The trial will conclude with an end-of-study visit, where final assessments will be conducted to gather comprehensive data on the study's endpoints.

The expected length of participant involvement is approximately six weeks, during which they will be required to adhere to the study protocol and attend all scheduled visits. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events that compromise participant safety, or withdrawal of consent. The trial is focused on understanding the drug's interaction with the body in a controlled environment, providing valuable insights into its potential application in treating **cancer**, specifically **non-small cell lung cancer**. The study's design and procedures are meticulously crafted to ensure the collection of high-quality data while maintaining participant safety and scientific integrity.

Treatment

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements cannot be provided.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

Efficacy

The clinical trial is in Phase 3, indicating it is designed to assess the efficacy and safety of the investigational treatment in a larger patient population. The trial is scheduled to begin recruitment on July 5, 2023, with an estimated end date of August 22, 2023. The efficacy of the treatment will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will likely involve systematic methods for measuring, collecting, and analyzing these efficacy parameters, consistent with standard practices in Phase 3 trials. The trial's design and execution will adhere to rigorous scientific and ethical standards to ensure the reliability and validity of the efficacy assessments.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Sex : male
Age : 18 years to 67 years; inclusive, at screening.
Body mass index (BMI): 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
Male subjects, if not surgically sterilized (vasectomy performed at least 4 months prior to dosing), must agree to use adequate contraception and not donate sperm from entry to the clinical research center until 90 days after follow¬up. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.
All prescribed medication, and all over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical research center. With accidental use, subjects can still be eligible for participation after discussion with the medical monitor. An exception is also made for paracetamol, which is allowed up to admission to the clinical research center (up to 2 g per day). Milk of Magnesia (ie, magnesium hydroxide) (≤30 mL per day) may be administered 24 hours after dosing at the discretion of the Investigator.
Any drugs known to be strong inducers of cytochrome P450 (CYP)3A, enzymes and/or P-glycoprotein, including St. John’s Wort, must have been stopped at least 28 days prior admission and throughout the study. Appropriate sources (eg, Flockhart Table™) will be consulted by the Investigator or authorized designee, to confirm lack of PK/pharmacodynamic interaction with study drug. The Sponsor’s study director should be contacted with any questions.
Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and admission to the clinical research center and until discharge.
Able to fast for at least 14 hours (ie, at least 10 hours prior to dosing and at least 4 hours after dosing).
Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, and energy drinks) and grapefruit (juice) from 48 hours (2 days) prior to admission to the clinical research center.
Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.
Willing and able to sign the ICF.

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Exclusion Criteria

Employee of ICON or the Sponsor.
History of relevant drug and/or food allergies.
Using tobacco products within 30 days prior to drug administration.
History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 2 years prior to dosing.
Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, cotinine, and alcohol) at screening or admission to the clinical research center.
Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
History and/or current evidence of any of the following disorders: • Ventricular dysfunction or risk factors for Torsades de Pointes (eg, heart failure, cardiomyopathy, family history of Long QT Syndrome); • QTcF >470 ms; • Unable to take medications by mouth due to medical conditions or previous surgery that may affect gastrointestinal function, including but not limited to inflammatory bowel diseases (eg, Crohn's disease, and ulcerative colitis) or malabsorption syndrome, or procedures that may affect gastrointestinal function, such as gastrectomy, enterectomy, or colectomy.
For a study with a radiation burden of >0.1 mSv, the subject will be excluded if he participated in another study with a radiation burden of >0.1 mSv and ≤1 mSv in the period of 1 year prior to screening; a radiation burden of >1.1 mSv and ≤2 mSv in the period of 2 years prior to screening; a radiation burden of >2.1 mSv and ≤3 mSv in the period of 3 years prior to screening, etc (add 1 year per 1 mSv).
Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical study in the period of 1 year prior to screening.
Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation (defined as less than 1 bowel movement every 2 days and/or requires treatment for constipation), within 2 weeks of dosing.
Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.
Participation in a drug study within 30 days prior to drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to drug administration in the current study.
Donation or loss of more than 450 mL of blood within 60 days prior to drug administration.
Plasma donation within 7 days prior to dosing.
Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator.
Unsuitable veins for blood sampling.