Food Effect and Mass Balance Study of XZP-3621 Tablets (NCT05034120) | Clinical Trial Compass
CompletedPhase 1
Food Effect and Mass Balance Study of XZP-3621 Tablets
China34 participantsStarted 2021-12-23
Plain-language summary
This is a single-center, open-label, single-dose phase I study, the study is divided into two stages. The stage 1 is to investigate the absorption, metabolism and excretion of XZP-3621 tablets in healthy Chinese subjects. The stage 2 is to evaluate the effect of food on the Pharmacokinetics of single-dose XZP-3621 tablets in Chinese Healthy Volunteers. In addition, the safety of XZP-3621 tablets in Chinese Healthy Volunteers will also be evaluated.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Healthy male or female subjects aged 18 to 65 (including 18 and 65);
✓. Male weight ≥50 kg, female weight ≥45 kg, body mass index in the range of 18-28 kg/m2 (including 18 and 28);
✓. No medical history of mental abnormalities, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
✓. Subjects agree to use effective contraceptive methods, such as condoms, contraceptive sponges, contraceptive gels, contraceptive membrane, intrauterine device, oral or injectable contraceptives, subcutaneous implants, or other contraceptive methods, from screening (2 weeks prior to screening for female subjects) to 6 months after the last dose;
✓. The subject can have a good communication with the investigators, understand and comply with the requirements of this study, understand and sign the informed consent voluntarily.
Exclusion criteria
✕. Hypersensitivity (hypersensitivity to two or more substances) or known hypersensitivity to XZP-3621 tablets/similar drugs;
✕. Abnormal examination during the screening period with clinical significance (to be determined by the investigator);
✕. Frequent use of sedatives、sleeping pills or other addictive drugs et al;
✕. Those who had a history of drug abuse or urine drug abuse screening positive within 12 months before enrollment;
✕. Smoking more than 5 cigarettes a day, or failing to stop using any tobacco products during the test period;
What they're measuring
1
AUC0-t(area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Timeframe: up to 192 hours
2
Cmax(maximum measured concentration of the analyte in plasma)
Timeframe: up to 192 hours
3
AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Timeframe: up to 192 hours
4
to determine the Mass Balance recovery of orally administered XZP-3621 and its metabolites in all (urine, faeces and vomits) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)
✕. Positive breath test for alcohol or regular drinkers in the 6 months prior to entry, i.e. drinking more than 3 units per day or more than 21 units per week (one unit is equivalent to a 350 mL bottle of beer or 120 mL of liquor or 30 mL of spirits (over 50°));
✕. Take any prescription medicine or Chinese herbal medicine within 4 weeks before enrollment, and/or Take any over-the-counter (OTC) drug or food supplement (including vitamins, calcium tablets and other health care products) within 2 weeks before the first administration of XZP-3621 tablet;
✕. Those who have participated in other clinical trials and taken experimental drugs within 3 months before enrollment;