Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects

NCT04951765 | Unknown Phase 1

• 1 other identifier: XZP-3287-1002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of XZP-3287 administered after a high or low-fat meal.

Conditions

Healthy

Keywords

XZP-3287; Food Effect; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Primary PK Endpoints

  Cmax

  day 1~day 21

• Primary PK Endpoints

  AUC0-∞

  day 1~day 21

• Primary PK Endpoints

  AUC0-t

  day 1~day 21

Secondary Outcomes (5)

• Secondary PK measures

  day 1~day 21

• Secondary PK measures

  day 1~day 21

• Secondary PK measures

  day 1~day 21

• Secondary PK measures

  day 1~day 21

• Safety and tolerability

  Up to 14 days after last dose

Study Arms (6)

Arm A

EXPERIMENTAL

Cycle1 Day 1：fasting；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：low-fat meal

Drug: XZP-3287

Arm B

EXPERIMENTAL

Cycle1 Day 1：high-fat meal；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：fasting

Drug: XZP-3287

Arm C

EXPERIMENTAL

Cycle1 Day 1：low-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：high-fat meal

Drug: XZP-3287

Arm D

EXPERIMENTAL

Cycle1 Day 1：fasting；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：high-fat meal

Drug: XZP-3287

Arm E

EXPERIMENTAL

Cycle1 Day 1：high-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：low-fat meal

Drug: XZP-3287

Arm F

EXPERIMENTAL

Cycle1 Day 1：low-fat meal；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：fasting

Drug: XZP-3287

Interventions

XZP-3287 DRUG

Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast

Arm A

Eligibility Criteria

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

You may qualify if:

• Healthy male or female subjects aged 18 to 65 years (including 18 and 65);
• Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive).
• No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
• Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form (for women, 2 weeks before trial screening) to the date of the last medication.
• Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent

You may not qualify if:

• Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients
• Abnormal clinical tests and clinical significance judged by the investigator
• Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment
• History of drug use, or drug abuse screening positive
• Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period
• Heavy drinking or regular drinking in the six months preceding the screening period
• Use of any prescription drug or Chinese herbal medicine within 4 weeks prior to enrollment, or use of any over-the-counter drug, any vitamin product, health care drug within 14 days prior to enrollment;
• Treatment with an investigational drug within 3 months
• Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.
• Had a severe infection, trauma or major surgery within 4 weeks of screening
• Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes
• Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required.
• Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.
• Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet
• habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Central Study Contacts

Cuilan Xiao

CONTACT

0086-13699167610; xiaocuilan@xuanzhubio.com

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: June 16, 2021
• First Posted: July 7, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-06

Locations

CN (1)