BridgeMD
A PHASE 1 STUDY TO ASSESS THE MASS BALANCE, PHARMACOKINETICS, AND METABOLISM OF ORAL [14C]-ZIPALERTINIB IN HEALTHY ADULT MALE SUBJECTS
EU CTIS ID: 2023-505085-28-00
What this study is testing
To assess the mass balance of zipalertinib following a single oral dose of [14C]-zipalertinib To quantify TRA concentration equivalents in plasma and whole blood following a single oral dose of [14C]-zipalertinib in healthy adult subjects To characterize the PK profile of zipalertinib in plasma and urine following a single oral dose of [14C]-zipalertinib in healthy adult subjects To determine the percentage of 14C radioactivity associated with cellular components in whole blood over time (eg, whole blood:plasma partitioning ratio)
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Sex : male
- 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.
- 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.
You likely can't join if
- Employee of ICON or the Sponsor.
- 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.
See the full eligibility criteria
Who can join
- Sex : male
- 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.
- 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.
What rules you out
- Employee of ICON or the Sponsor.
- 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.
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.