Food Effect and Mass Balance Study of XZP-3621 Tablets

NCT05034120 | Completed Phase 1

• 1 other identifier: XZP-3621-1002
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

XZP-3621; Food-Effect; Mass Balance

Outcome Measures

Primary Outcomes (4)

• 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)

  Pharmacokinetic Data Analysis for XZP-3621 and its metabolites

  up to 192 hours

• Cmax(maximum measured concentration of the analyte in plasma)

  Pharmacokinetic Data Analysis for XZP-3621 and its metabolites

  up to 192 hours

• AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  Pharmacokinetic Data Analysis for XZP-3621 and its metabolites

  up to 192 hours

• 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)

  cumulative excretions after a single dose of XZP-3621 and its metabolites in urine, feces and vomits.

  MB stage:Day1-Day9

Secondary Outcomes (3)

• Tmax(the time from dosing at which Cmax was apparent)

  up to 192 hours

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  MB Stage:28±3 days,FE Stage:47±3 days

• T1/2(Apparent terminal elimination half-life )

  up to 192 hours

Study Arms (7)

MB:Single arm

EXPERIMENTAL

10 subjects will be enrolled in this arm. The subjects will take a single dose XZP-3621 tablet after a low-fat meal and perform excretion collection consistently.

Drug: XZP-3621

FE:Arm A

EXPERIMENTAL

Cycle1 Day1: fasting; Cycle2 Day10: High-fat meal; Cycle3 Day19: Low-fat meal

Drug: XZP-3621

FE:Arm B

EXPERIMENTAL

Cycle1 Day1: High-fat meal; Cycle2 Day10: Low-fat meal; Cycle3 Day19: fasting

Drug: XZP-3621

FE:Arm C

EXPERIMENTAL

Cycle1 Day1: Low-fat meal; Cycle2 Day10: fasting; Cycle3 Day19: High-fat meal

Drug: XZP-3621

FE:Arm D

EXPERIMENTAL

Cycle1 Day1: fasting; Cycle2 Day10: Low-fat meal; Cycle3 Day19: High-fat meal

Drug: XZP-3621

FE:Arm E

EXPERIMENTAL

Cycle1 Day1: High-fat meal; Cycle2 Day10: fasting; Cycle3 Day19: Low-fat meal

Drug: XZP-3621

FE:Arm F

EXPERIMENTAL

Cycle1 Day1: Low-fat meal; Cycle2 Day10: High-fat meal; Cycle3 Day19:fasting

Drug: XZP-3621

Interventions

XZP-3621 DRUG

Administer a single dose of XZP-3621 tablet after a low-fat meal.

MB:Single arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who meet all of the requirements as follows will be included.
• 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.

You may not qualify if:

• Subject who meet either of the requirements as follows will be excluded.
• 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;
• 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;
• Blood donation (including component blood donation) or blood loss of 400 mL within 3 months before enrollment, or blood transfusion;Blood donation (including component blood donation) or blood loss of 200 mL within 1 month before the test;
• Have a history of major disease or major surgery or trauma 3 months before screening;
• A history of gastrointestinal disease causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or a history of severe vomiting or diarrhea within the week prior to enrollment;
• Female subjects during pregnancy and lactation and female subjects of childbearing age who cannot use contraception as required;
• Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
• Have special dietary requirements (including lactose intolerance) and fail to comply with the provided diet and corresponding regulations;

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Study Officials

• Yu Cao

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 5, 2021
• Study Start: December 23, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: May 25, 2025

Record last verified: 2021-08

Locations

CN (1)