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An open-label, single-dose phase 1 study to evaluate the Absorption, Metabolism, and Excretion of [14C]-AZ-3102 in Healthy Male Subjects
EU CTIS ID: 2023-504916-14-00
What this study is testing
To determine the routes and rates of elimination of drug-related materials by assessing the mass balance (i.e., cumulative excretion of total radioactivity in urine and feces) following a single oral administration of 9 mg (~3.7 MBq [100 μCi]) [14C]-AZ-3102. To assess the metabolic profile of AZ-3102 in plasma, urine, and feces following a single oral administration of 9 mg (~3.7 MBq [100 μCi]) [14C]-AZ-3102. To characterize the pharmacokinetic (PK) of total radioactivity in applicable matrices following a single oral solution dose of 9 mg (~3.7 MBq [100 μCi]) [14C]- AZ-3102.
- 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
- Able and willing to give written informed consent and willing to comply with the requirements and restrictions of the study.
- Negative results from urine drug screen at screening and Day -1.
- Ability to communicate well with the investigator and to understand and comply with the requirements of the study.
- Healthy male subjects aged between 18 and 65 years (inclusive) at screening.
- A male participant with a female partner of childbearing potential is eligible if he agrees to follow the contraceptive guidance during the study and for up to 14 weeks post discharge from the clinic.
- Willing to refrain from sperm donation during the study and for up to 14 weeks post discharge from the clinic.
You likely can't join if
- Participation in another mass balance study with a radiation burden. • >0.1 mSv and up to 1.0 mSv in the period of 1 year prior to screening. • from 1.1 and up to 2.0 mSv in the period of 2 years prior to screening. • or 2.1 and up to 3.0 mSv in the period of 3 years prior to screening.
- History of chronic dermatological conditions that required medical follow-up.
- History of corneal erosions, degenerations and active or recurrent keratitis.
- Veins unsuitable for intravenous (i.v.) puncture on either arm (e.g., veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture).
- Previous exposure to the study medication.
- Treatment with another investigational treatment within 3 months prior to dosing or participation in more than four investigational treatment studies within 1 year prior to dosing.
See the full eligibility criteria
Who can join
- Able and willing to give written informed consent and willing to comply with the requirements and restrictions of the study.
- Negative results from urine drug screen at screening and Day -1.
- Ability to communicate well with the investigator and to understand and comply with the requirements of the study.
- Healthy male subjects aged between 18 and 65 years (inclusive) at screening.
- A male participant with a female partner of childbearing potential is eligible if he agrees to follow the contraceptive guidance during the study and for up to 14 weeks post discharge from the clinic.
- Willing to refrain from sperm donation during the study and for up to 14 weeks post discharge from the clinic.
- No clinically significant findings on the physical examination at screening.
- Body mass index (BMI) of 18.0 to 30.5 kg/m2 (inclusive) at screening.
- Systolic blood pressure (SBP) 90-140 mmHg, diastolic blood pressure (DBP) 45-90 mmHg, and pulse rate 40-100 beats per minute (bpm) (inclusive), measured at screening.
- 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after at least 5 minutes in the supine or semi-supine position at screening.
- Hematology, coagulation, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
What rules you out
- Participation in another mass balance study with a radiation burden. • >0.1 mSv and up to 1.0 mSv in the period of 1 year prior to screening. • from 1.1 and up to 2.0 mSv in the period of 2 years prior to screening. • or 2.1 and up to 3.0 mSv in the period of 3 years prior to screening.
- History of chronic dermatological conditions that required medical follow-up.
- History of corneal erosions, degenerations and active or recurrent keratitis.
- Veins unsuitable for intravenous (i.v.) puncture on either arm (e.g., veins that are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture).
- Previous exposure to the study medication.
- Treatment with another investigational treatment within 3 months prior to dosing or participation in more than four investigational treatment studies within 1 year prior to dosing.
- History or clinical evidence of alcoholism or drug abuse within the 2-year period prior to screening.
- Excessive caffeine consumption, defined as ≥ 800 mg per day at screening (for reference: 1 soft drink has between 30-40 mg caffeine, 1 cup of coffee 80-100 mg, and 1 energy drink between 40 to 250 mg)1.
- Smoking within 3 months prior to screening and inability to refrain from smoking during the study.
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including homeopathic preparations, herbal medicines such as St John’s Wort, vitamins, and minerals) within 2 weeks or 5 half-lives (whichever is longer) for prescribed- and 7 days for OTC medication prior to study drug administration. An exception is made for paracetamol, which is allowed up to admission to the clinic.
- Blood loss deemed significant by the investigator within 3 months prior to screening, or any amount of plasma in the 7 days prior to screening, or any amount of platelets in the 42 days prior to screening.
- Exposure to radiation (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), in the period of 1 year prior to screening.
- Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening.
- Positive results from the human immunodeficiency virus (HIV) serology at screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol or might confound the results of the study.
- Legal incapacity or limited legal capacity at screening.
- Known hypersensitivity to the study medication or to drugs of the same class (iminosugars/azasugars).
- History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Estimated creatinine clearance <90 mL/min at screening.
- Subject has infrequent bowel movements (on average less than once per 2 days) within 2 weeks prior to dosing.
- Recent history of abnormal bowel movements, such as diarrhea, loose stools, within 2 weeks prior to dosing.
- History of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions in the past year that generates a risk for participation in the current study as based on investigator judgment.
- History of seizure.
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.