A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects

NCT05150626 | Completed Phase 1

• 1 other identifier: HA1118-013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, three-period, crossover, single-dose study to evaluate the effects of a low-fat meal and a standard meal on the pharmacokinetics of DBPR108 and the safety and tolerability of DBPR108 under different fed states in healthy adult subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Peak plasma concentration (Cmax) of DBPR108

  Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

• Area under the plasma concentration versus time curve from time zero to the time of last measurable concentration (AUClast) of DBPR108

  Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

• Area under the plasma concentration versus time curve from time zero to infinity (AUCinf) of DBPR108

  Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

Secondary Outcomes (5)

• Time to achieve maximum plasma concentration (Tmax) of DBPR108

  Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

• Half-life (t1/2) of DBPR108

  Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

• Apparent clearance (CL/F) of DBPR108

  Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

• Apparent volume of Distribution (Vz/F) of DBPR108

  Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

• Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0

  Day 1 to Day 14

Study Arms (3)

Sequence A administered DBPR108

EXPERIMENTAL

Subjects will receive a single dose of DBPR108 100 mg under fasted condition, following a low-fat meal and a standard meal.

Drug: DBPR108 tablets

Sequence B administered DBPR108

EXPERIMENTAL

Subjects will receive a single dose of DBPR108 100 mg following a low-fat meal and standard meal, under fasted condition.

Drug: DBPR108 tablets

Sequence C administered DBPR108

EXPERIMENTAL

Subjects will receive a single dose of DBPR108 100 mg following a standard meal, under fasted condition, following a low-fat meal.

Drug: DBPR108 tablets

Interventions

DBPR108 tablets DRUG

Drug: DBPR108, tablets, oral

Sequence A administered DBPR108; Sequence B administered DBPR108; Sequence C administered DBPR108

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects fully understand and voluntarily participate in this study and sign informed consent;
• Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive);
• Body Mass Index (BMI) of 18 to 28 kg/m2 (inclusive), body weight for male ≥50.0 kg and for female≥45.0 kg；
• Subjects (including their partners) are willing to use effective contraceptives from screening to the 6 months after the last dose administration;
• Subjects judged to be in good health by the investigator, based on the physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination and laboratory examination etc;

You may not qualify if:

• History of allergic conditions, or allergic to any ingredients of DBPR108;
• History of severe diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases within 1 year prior to screening;
• History of hypoglycemia or abnormal blood glucose at screening: fasting blood glucose \<70 mg/dL (3.9 mmol/L) or \>110 mg/dL (6.1 mmol/L);
• Subjects who have previously undergone surgery (e.g., subtotal gastrectomy) that may affect the absorption, distribution, metabolism, or excretion of the drug, or who have a scheduled surgery during the study period;
• History of drug abuse, or urine drug screening is positive at screening;
• Smoking more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using nicotine-containing products during the study period;
• Regular alcohol consumption exceeding 15 g/day(female) or 25 g/day(male) (15 g ≈ 450 mL beer, or 50 mL hard liquor, or 150 mL wine) within the 3 months prior to screening, or taking any product containing alcohol within 48 h before dosing, or alcohol test is positive;
• Blood donation (or blood loss) ≥400 mL, or receiving blood product transfusion within 3 months prior to screening;
• Consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks), or those who have had strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, within 48 h before the administration;
• Use of any prescription drug, over-the-counter drug (except acetaminophen and some nasal sprays), or herbal medicine within 2 weeks prior to screening;
• Have special dietary requirements and cannot consume the study meals;
• Subject with hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or Treponema pallidum antibody positive;
• Enrolled in any other clinical trial within 3 months before screening (whichever is administrated);
• Have been vaccinated within 4 weeks prior to screening or who have a scheduled vaccination during the study period;
• Pregnant/lactating woman, or who has a positive blood pregnancy test at screening;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Soochow University

Suzhou, China

Location

MeSH Terms

Interventions

DBPR108

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: November 26, 2021
• First Posted: December 9, 2021
• Study Start: May 29, 2022
• Primary Completion: June 7, 2022
• Study Completion: July 14, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)