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

A Phase I Study to Examine the Effects of Low and High-fat Meals on Orally Administered XZP-3287 in Healthy Adult Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: XZP-3287; Drug: XZP-3287; Drug: XZP-3287; Drug: XZP-3287; Drug: XZP-3287; Drug: XZP-3287

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cuilan Xiao; Phone Number: 0086-13699167610; Email: xiaocuilan@xuanzhubio.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Yu Cao; Phone Number: 0086-0532-82911767; Email: Caoyu1767@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion Criteria

1. Healthy male or female subjects aged 18 to 65 years (including 18 and 65);
2. Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive).
3. No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
4. 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.
5. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent

Exclusion Criteria:

1. Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients
2. Abnormal clinical tests and clinical significance judged by the investigator
3. Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment
4. History of drug use, or drug abuse screening positive
5. 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
6. Heavy drinking or regular drinking in the six months preceding the screening period
7. 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;
8. Treatment with an investigational drug within 3 months
9. Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.
10. Had a severe infection, trauma or major surgery within 4 weeks of screening
11. Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes
12. Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required.
13. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.
14. Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet
15. habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period
16. habitual consumption of grapefruit juice during the study period
17. have difficulty in blood collection or cannot tolerate vein puncture for blood collection
18. As determined by the investigator, the subject has other factors that are not suitable for the study -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Cycle1 Day 1：fasting；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：low-fat meal	Drug: XZP-3287; 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; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; 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 low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing 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 before starting a low-fat breakfast
Experimental: Arm B; Cycle1 Day 1：high-fat meal；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：fasting	Drug: XZP-3287; 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; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; 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 low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing 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 before starting a low-fat breakfast
Experimental: Arm C; Cycle1 Day 1：low-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：high-fat meal	Drug: XZP-3287; 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; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; 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 low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing 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 before starting a low-fat breakfast
Experimental: Arm D; Cycle1 Day 1：fasting；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：high-fat meal	Drug: XZP-3287; 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; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; 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 low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing 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 before starting a low-fat breakfast
Experimental: Arm E; Cycle1 Day 1：high-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：low-fat meal	Drug: XZP-3287; 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; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; 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 low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing 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 before starting a low-fat breakfast
Experimental: Arm F; Cycle1 Day 1：low-fat meal；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：fasting	Drug: XZP-3287; 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; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; 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 low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast; Drug: XZP-3287; Cycle1 Day 1: one dose of XZP-3287 after finishing 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 before starting a low-fat breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary PK measures	Tmax	day 1~day 21
Secondary PK measures	T1/2	day 1~day 21
Secondary PK measures	CL/F	day 1~day 21
Secondary PK measures	Vz/F	day 1~day 21
Safety and tolerability	Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0	Up to 14 days after last dose

Collaborators and Investigators

• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Food Effect; XZP-3287
• Other Study ID Numbers: XZP-3287-1002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No