A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects

NCT04859452 | Completed Phase 1

• 1 other identifier: HA1118-CSP-010
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a four-part, single-center, open-label, single-sequence crossover phase I clinical study to characterize the Drug-Drug Interaction (DDI) potential of DBPR108 at steady-state with Metformin hydrochloride, Glibenclamide, Valsartan, or Simvastatin in Healthy Subjects. This study also aims to evaluate the safety and tolerability of DBPR108 in the presence of Metformin hydrochloride, Glibenclamide, Valsartan, or Simvastatin.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• The pharmacokinetic parameters of Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid and DBPR108

  Peak Plasma Concentration (Cmax)

  Day 1 to Day 9

• The pharmacokinetic parameters of Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid and DBPR108

  Area under the plasma concentration versus time curve (AUC)

  Day 1 to Day 9

Secondary Outcomes (5)

• The pharmacokinetic parameters

  Day 1 to Day 9

• The pharmacokinetic parameters

  Day 1 to Day 9

• The pharmacokinetic parameters

  Day 1 to Day 9

• The pharmacokinetic parameters

  Day 1 to Day 9

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

  Day 1 to Day 15

Study Arms (4)

The DDI of DBPR108 tablets and Metformin hydrochloride tablets

EXPERIMENTAL

Subjects will receive a single dose of metformin hydrochloride on Day 1, then take once-daily DBPR108 100 mg on Day 4 through Day 8 and a single dose of metformin hydrochloride on Day 8.

Drug: DBPR108 tablets; Drug: Metformin hydrochloride tablets

The DDI of DBPR108 tablets and Glibenclamide tablets

EXPERIMENTAL

Subjects will receive a single dose of Glibenclamide on Day 1, then take once-daily DBPR108 100 mg on Day 4 through Day 8 and a single dose of Glibenclamide on Day 8.

Drug: DBPR108 tablets; Drug: Glibenclamide tablets

The DDI of DBPR108 tablets and Valsartan Capsules

EXPERIMENTAL

Subjects will receive a single dose of Valsartan on Day 1, then take once-daily DBPR108 100 mg on Day 4 through Day 8 and a single dose of Valsartan on Day 8.

Drug: DBPR108 tablets; Drug: Valsartan Capsules

The DDI of DBPR108 tablets and Simvastatin tablets

EXPERIMENTAL

Subjects will receive a single dose of Simvastatin on Day 1, then take once-daily DBPR108 100 mg on Day 4 through Day 8 and a single dose of Simvastatin on Day 8.

Drug: DBPR108 tablets; Drug: Simvastatin tablets

Interventions

DBPR108 tablets DRUG

Drug: DBPR108, tablet, oral

Also known as: DBPR108

The DDI of DBPR108 tablets and Glibenclamide tablets; The DDI of DBPR108 tablets and Metformin hydrochloride tablets; The DDI of DBPR108 tablets and Simvastatin tablets; The DDI of DBPR108 tablets and Valsartan Capsules

Metformin hydrochloride tablets DRUG

Drug: Metformin hydrochloride, tablet, oral

The DDI of DBPR108 tablets and Metformin hydrochloride tablets

Glibenclamide tablets DRUG

Drug: Glibenclamide, tablet, oral

The DDI of DBPR108 tablets and Glibenclamide tablets

Valsartan Capsules DRUG

Drug: Valsartan, capsule, oral

The DDI of DBPR108 tablets and Valsartan Capsules

Simvastatin tablets DRUG

Drug: Simvastatin, tablet, oral

The DDI of DBPR108 tablets and Simvastatin tablets

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions；
• years to 45 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；
• Be judged to be in good health by the investigator, based on the physical examination, vital sign examination, 12-lead electrocardiogram (ECG) examination and laboratory examination；

You may not qualify if:

• 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 diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within 1 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 prescription drug, over-the-counter drug, or herbal medicine within 2 weeks prior to 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；
• The patients who have undergone comprehensive inspection with any significant clinical significant in physical examination (vital signs, physical examination), routine laboratory examination (blood routine, blood biochemical examination, urine routine), chest X-ray (anteroposterior), abdominal B (liver, bile, pancreas, spleen and kidney) and other examinations, as judged by the investigator;
• Have a positive test result of hepatitis B surface antigen, hepatitis C antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
• A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial.；
• Not suitable for this study as judged by the investigator；

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; Metformin; Glyburide; Valsartan; Simvastatin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sulfonylurea Compounds; Urea; Amides; Sulfones; Sulfur Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

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: May 26, 2021
• Primary Completion: July 3, 2021
• Study Completion: July 9, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-04

Locations

CN (1)