A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment

NCT04859426 | Completed Phase 1

• 1 other identifier: HA1118-CSP-008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• The pharmacokinetic parameters of DBPR108

  Cmax

  Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing

• The pharmacokinetic parameters of DBPR108

  AUC0-t

  Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing

• The pharmacokinetic parameters of DBPR108

  AUC0-inf

  Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing

Secondary Outcomes (5)

• The pharmacokinetic parameters of DBPR108

  Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing

• The pharmacokinetic parameters of DBPR108

  Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing

• The pharmacokinetic parameters of DBPR108

  Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing

• The pharmacokinetic parameters of DBPR108

  Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing

• The number of volunteers with adverse events as a measure of safety and tolerability

  Day 1 to Day6

Study Arms (3)

Mild Hepatic Impairment

EXPERIMENTAL

Subjects will receive a single dose of 100 mg DBPR108.

Drug: DBPR108 tablets

Moderate Hepatic Impairment

EXPERIMENTAL

Subjects will receive a single dose of 100 mg DBPR108.

Drug: DBPR108 tablets

Normal hepatic function

EXPERIMENTAL

Subjects will receive a single dose of 100 mg DBPR108.

Drug: DBPR108 tablets

Interventions

DBPR108 tablets DRUG

Drug: DBPR108, tablet, oral

Also known as: DBPR108

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal hepatic function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects:
• Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions；
• years to 79 years (inclusive), male or female；
• Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height 2 (m2))；
• Subjects (including partners) are willing to use effective contraceptives from screening to the 6 months after the last dose administration；
• Subjects with HI only:
• Medically stable hepatic impairment on the Child-Pugh Class A (mild) or Child-Pugh Class B (moderate) caused by a primary hepatic disease;
• Not in use of any prescription drug, over-the-counter drug, or herbal medicine within 2 weeks prior to screening, except for the medication necessary for hepatic impairment/ other comorbidities (last more than four weeks in good compliance);
• Subjects with normal liver function only:
• Weight, age, and sex must be matched with subjects with HI;
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) results within normal range;
• Not in use of any prescription drug, over-the-counter drug, or herbal medicine within 2 weeks prior to screening, except for the medication necessary for underlying conditions other than liver disease (last more than four weeks in good compliance);

You may not qualify if:

• All subjects:
• Subjects who have a history of allergic conditions (such as asthma, urticaria), or have a history of allergy to two or more drugs or food, or may be allergic to the test drug and the related compounds;
• Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening；
• Subjects who have previously undergone surgery that may affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or who have a scheduled surgical plan during the study period;
• Use of any DPP-IV enzyme inhibitor within 2 weeks prior to the screening;
• Drug abuse, or positive urine drug screen at screening；
• Smoking more than 5 cigarettes per day within 3 months prior to screening；
• Average alcohol intake is more than 28g alcohol (male) or 14g (female) per week (14g ≈ 497mL beer, or 44mL spirits with low alcohol content, or 145mL wine) within the 3 months prior to screening, or taking any alcohol within 48 hours before dosing, or a positive ethanol breath test at screening；
• Consumption of grapefruit juice, Methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 48 hours before the administration, or have strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, etc.；
• Participation in another clinical trial within 3 months before screening；
• Blood donation (or blood loss) ≥400 mL, or receiving whole blood transfusions or erythrocyte suspension transfusions within 3 months prior to the screening；
• A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial；
• Estimated glomerular filtration rate (eGFR)\<90 mL/min/1.73 m2 calculated by the modification of diet in renal diseases (MDRD) equation at screening；
• Have a positive test result of human immunodeficiency virus (HIV) antibody, or anti-Treponema pallidum specific antibody；
• Currently receiving, or unable to refrain from expected concomitant cytochrome (CYP) 3A inhibitors and inducers;

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: June 9, 2021
• Primary Completion: May 14, 2022
• Study Completion: May 17, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)