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

July 19, 2021 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

A Four-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-Drug Pharmacokinetic Interaction Between DBPR108 at Steady-state and Metformin Hydrochloride/Glibenclamide/Valsartan/ Simvastatin in Healthy Subjects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. This study will be run in four parts to characterize the Drug-Drug Interaction (DDI) potential of DBPR108 with the expected concomitant drugs (Metformin hydrochloride, Glibenclamide, Valsartan, Simvastatin) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 9), and a follow-up visit on Day 15. Approximately 14 subjects will be enrolled in each part of this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Suzhou, China
        • First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions；
  • 18 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；

Exclusion Criteria:

  • 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；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The DDI of DBPR108 tablets and Metformin hydrochloride tablets
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: DBPR108, tablet, oral
Other Names:
  • DBPR108
Drug: Metformin hydrochloride tablets
Drug: Metformin hydrochloride, tablet, oral
Experimental: The DDI of DBPR108 tablets and Glibenclamide tablets
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: DBPR108, tablet, oral
Other Names:
  • DBPR108
Drug: Glibenclamide tablets
Drug: Glibenclamide, tablet, oral
Experimental: The DDI of DBPR108 tablets and Valsartan Capsules
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: DBPR108, tablet, oral
Other Names:
  • DBPR108
Drug: Valsartan Capsules
Drug: Valsartan, capsule, oral
Experimental: The DDI of DBPR108 tablets and Simvastatin tablets
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: DBPR108, tablet, oral
Other Names:
  • DBPR108
Drug: Simvastatin tablets
Drug: Simvastatin, tablet, oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The pharmacokinetic parameters of Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid and DBPR108
Time Frame: Day 1 to Day 9
Peak Plasma Concentration (Cmax)
Day 1 to Day 9
The pharmacokinetic parameters of Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid and DBPR108
Time Frame: Day 1 to Day 9
Area under the plasma concentration versus time curve (AUC)
Day 1 to Day 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The pharmacokinetic parameters
Time Frame: Day 1 to Day 9
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : Tmax
Day 1 to Day 9
The pharmacokinetic parameters
Time Frame: Day 1 to Day 9
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : t1/2
Day 1 to Day 9
The pharmacokinetic parameters
Time Frame: Day 1 to Day 9
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : Vz/F
Day 1 to Day 9
The pharmacokinetic parameters
Time Frame: Day 1 to Day 9
The pharmacokinetic parameters (Metformin, Glibenclamide, Valsartan, Simvastatin, Simvastatin acid, DBPR108) : CL/F
Day 1 to Day 9
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: Day 1 to Day 15
The number of volunteers with adverse events as a measure of safety and tolerability
Day 1 to Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HA1118-CSP-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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