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Healthy SubjectsPhase 1NCT05045313

A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects

A Phase 1 study testing Warfarin sodium tablets, Digoxin tablet and Probenecid tablets in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a three-part, single-center, open-label phase I clinical study to characterize the DDIs potential of DBPR108 with Warfarin sodium, Digoxin, or Probenecid in healthy subjects. This study also aims to evaluate the safety and tolerability of DBPR108 in the presence of Warfarin sodium, Digoxin, or Probenecid. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
Warfarin sodium tablets, Digoxin tablet and Probenecid tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
20 Oct 2021to 1 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
  • 18 to 45 years (inclusive), male and female;
  • Male subjects weight ≥50.0 kg and female subjects weight ≥45.0 kg. Body mass index (BMI): 18-28 kg/m^2 (inclusive) (BMI= weight (kg)/height^2 (m^2)；
  • 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;

Who cannot join

  • Subjects who have a history of allergic conditions (such as asthma, urticaria), or have a history of allergy to any of the study drugs or other similarly structured drugs;
  • Subjects with a history of severe diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases within 1 year prior to screening;
  • Subjects with a 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 that may affect the absorption, distribution, metabolism, or excretion of the drug (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;
  • Have been vaccinated within 4 weeks prior to screening or who have a scheduled vaccinated plan during the study period;
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  • History of drug abuse, or positive urine drug screen at screening;
  • Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period；
  • Average daily intake of alcohol is more than 28 g alcohol (male) or 14 g (female) (14 g ≈ 497 mL beer, or 44 mL spirits with low alcohol content, or 145 mL wine) within the 3 months prior to screening, or taking any product containing alcohol within 48 h 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 h before the administration, or those who have had strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, etc;
  • Participation in another clinical trial within 3 months before screening (whichever is administrated)；
  • Blood donation (or blood loss) ≥400 mL, or receiving whole blood transfusions or erythrocyte suspension transfusions within 3 months prior to the screening;
  • Any positive test result of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
  • Pregnant/lactating woman, or has a positive pregnancy test at screening;
  • Not suitable for this study as judged by the investigator;
  • Supplementary exclusion criteria for the first part of the study: subjects with bleeding tendency, or PT and INR test results judged by the investigator to be not suitable for participating in the study;
  • Supplementary exclusion criteria for the third part of the study: the estimated glomerular filtration rate (eGFR) calculated by the modification of diet in renal diseases (MDRD) equation at screening with clinical significance as judged by the investigator, or subjects with nephrolithiasis or have a history of nephrolithiasis.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital of Soochow University

    Suzhou

Other trials in China

About this study

Official title: A Three-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-drug Interactions (DDIs) Between DBPR108 and Warfarin Sodium/Digoxin/Probenecid in Healthy Subjects

This is a three-part, single-center, open-label phase I clinical study to characterize the DDIs potential of DBPR108 with Warfarin sodium, Digoxin, or Probenecid in healthy subjects. This study also aims to evaluate the safety and tolerability of DBPR108 in the presence of Warfarin sodium, Digoxin, or Probenecid.

Read the detailed description

DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. This study will be run in three parts to characterize the DDIs potential of DBPR108 with the expected concomitant drugs (Warfarin sodium, Digoxin, Probenecid) 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, and a follow-up visit period. Approximately 14 subjects will be enrolled in each part of this study.

Being tested
Warfarin sodium tablets, Digoxin tablet, Probenecid tablets, DBPR108 tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Warfarin sodium tabletsDrug

    Drug: Warfarin sodium, tablet, oral

  • Digoxin tabletDrug

    Drug: Digoxin, tablet, oral

  • Probenecid tabletsDrug

    Drug: Probenecid, tablet, oral

  • DBPR108 tabletsDrug

    Also called DBPR108

    Drug: DBPR108, tablet, oral

Study groups in NCT05045313
Study groupRoleWhat they receive
The DDI of DBPR108 and Warfarin Sodium TabletsExperimentalSubjects will receive a single dose of Warfarin sodium 5 mg on Day 1, then take DBPR108 100 mg once-daily on Day 15 through Day 26 and a single dose of Warfarin sodium 5 mg on Day 19.
Receives: Drug: Warfarin sodium tablets; Drug: DBPR108 tablets
The DDI of DBPR108 and Digoxin TabletsExperimentalSubjects will receive a single dose of Digoxin 0.25 mg on Day 1, then take DBPR108 100 mg once-daily on Day 6 through Day 15 and a single dose of Digoxin 0.25 mg on Day 10.
Receives: Drug: Digoxin tablet; Drug: DBPR108 tablets
The DDI of DBPR108 and Probenecid TabletsExperimentalSubjects will receive a single dose of DBPR108 100 mg on Day 1, then take Probenecid 500 mg twice-daily on Day 5 through Day 9 and a single dose of DBPR108 100 mg on Day 7.
Receives: Drug: Probenecid tablets; Drug: DBPR108 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part one: Peak plasma concentration (Cmax) of S-warfarin and R-warfarin

    Measured: Day 1 to Day 8, and Day 19 to Day 26

  2. Part one: Area under the plasma concentration versus time curve (AUC) of S-warfarin and R-warfarin

    Measured: Day 1 to Day 8, and Day 19 to Day 26

  3. Part one: Peak plasma concentration (Cmax) of DBPR108

    Measured: Day 17 to Day 20

  4. Part one: Area under the plasma concentration versus time curve (AUC) of DBPR108

    Measured: Day 17 to Day 20

  5. Part two: Peak plasma concentration (Cmax) of Digoxin

    Measured: Day 1 to Day 6, and Day 10 to Day 15

  6. Part two: Area under the plasma concentration versus time curve (AUC) of Digoxin

    Measured: Day 1 to Day 6, and Day 10 to Day 15

  7. Part two: Peak plasma concentration (Cmax) of DBPR108

    Measured: Day 8 to Day 11

  8. Part two: Area under the plasma concentration versus time curve (AUC) of DBPR108

    Measured: Day 8 to Day 11

  9. Part three: Peak plasma concentration (Cmax) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

  10. Part three: Area under the plasma concentration versus time curve (AUC) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

Secondary outcomes (45)

  1. Part one: Time to achieve maximum plasma concentration (Tmax) of S-warfarin and R-warfarin

    Measured: Day 1 to Day 8, and Day 19 to Day 26

  2. Part one: Half-life(t1/2) of S-warfarin and R-warfarin

    Measured: Day 1 to Day 8, and Day 19 to Day 26

  3. Part one: Apparent volume of Distribution(Vz/F) of S-warfarin and R-warfarin

    Measured: Day 1 to Day 8, and Day 19 to Day 26

  4. Part one: Apparent clearance(CL/F) of S-warfarin and R-warfarin

    Measured: Day 1 to Day 8, and Day 19 to Day 26

  5. Part one: Time to achieve maximum plasma concentration (Tmax) of DBPR108

    Measured: Day 17 to Day 20

  6. Part one: Half-life(t1/2) of DBPR108

    Measured: Day 17 to Day 20

  7. Part one: Apparent volume of Distribution(Vz/F) of DBPR108

    Measured: Day 17 to Day 20

  8. Part one: Apparent clearance(CL/F) of DBPR108

    Measured: Day 17 to Day 20

  9. Part one: the pharmacodynamic parameters-Prothrombin time(PT)

    Measured: Day 1 to Day 8, and Day 19 to Day 26

  10. Part one: the pharmacodynamic parameters-International normalized ratio(INR)

    Measured: Day 1 to Day 8, and Day 19 to Day 26

  11. Part two: Time to achieve maximum plasma concentration (Tmax) of Digoxin

    Measured: Day 1 to Day 6, and Day 10 to Day 15

  12. Part two: Half-life(t1/2) of Digoxin

    Measured: Day 1 to Day 6, and Day 10 to Day 15

  13. Part two: Apparent volume of Distribution(Vz/F) of Digoxin

    Measured: Day 1 to Day 6, and Day 10 to Day 15

  14. Part two: Apparent clearance(CL/F) of Digoxin

    Measured: Day 1 to Day 6, and Day 10 to Day 15

  15. Part two: Time to achieve maximum plasma concentration (Tmax) of DBPR108

    Measured: Day 8 to Day 11

  16. Part two: Half-life(t1/2) of DBPR108

    Measured: Day 8 to Day 11

  17. Part two: Apparent volume of Distribution(Vz/F) of DBPR108

    Measured: Day 8 to Day 11

  18. Part two: Apparent clearance(CL/F) of DBPR108

    Measured: Day 8 to Day 11

  19. Part three: Time to achieve maximum plasma concentration (Tmax) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

  20. Part three: Half-life(t1/2) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

  21. Part three: Apparent volume of Distribution(Vz/F) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

  22. Part three: Apparent clearance(CL/F) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

  23. Part three:Cumulative amount of drug excreted in urine(Ae) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

  24. Part three: Cumulative fraction of the dose excreted(fe) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

  25. Part three: Renal Clearance(CLR) of DBPR108

    Measured: Day 1 to Day 3, and Day 7 to Day 9

  26. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Number of participants with treatment-related adverse events will be assessed by CTCAE v5.0. The AEs will be summarized according to the system organ class (SOC) and preferred term (PT), including the number and percentage of participants who had AEs.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  27. Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.

    ECG monitoring includes heart rate in bpm.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  28. Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.

    ECG monitoring includes P-R, QT and QTc intervals in ms.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  29. Clinically significant changes from baseline in physical examination will be recorded as AEs at each visit time point.

    Physical examination includes general conditions, skin, mucous membranes, head, neck, chest, abdomen, spine, limbs, nervous system, and lymphatic system.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  30. Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.

    Vital signs monitoring includes body temperature in degrees Celsius.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  31. Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.

    Vital signs monitoring includes respiratory rate and pulse in times per minute.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  32. Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.

    Vital signs monitoring includes systolic blood pressure and diastolic blood pressure in mmHg.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  33. Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.

    Routine blood test includes red blood cell count in 10^12/L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  34. Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.

    Routine blood test includes hemoglobin in g/L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  35. Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.

    Routine blood test includes hematocrit in L/L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  36. Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.

    Routine blood test includes white blood cell count, platelet, neutrophilic granulocyte count, lymphocyte count and monocyte count in 10^9 /L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  37. Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.

    Blood biochemistry test includes total protein and albumin in g/L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  38. Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.

    Blood biochemistry test includes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and glutamyltranspeptidase in U/L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  39. Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.

    Blood biochemistry test includes total bilirubin and serum creatinine in umol/L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  40. Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.

    Blood biochemistry test includes urea in mmol/L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  41. Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.

    Routine urine test includes urobilinogen, glucose and protein in mg/dL.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  42. Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.

    Routine urine test includes pH.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  43. Clinically significant changes from baseline in coagulation function test will be recorded as AEs at each visit time point.

    Coagulation action test includes fibrinogen in g/L.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  44. Clinically significant changes from baseline in coagulation function test will be recorded as AEs at each visit time point.

    Coagulation action test includes prothrombin time, thrombin time and activated partial thromboplatin time in seconds.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

  45. Clinically significant changes from baseline in coagulation function test will be recorded as AEs at each visit time point.

    Coagulation action test includes international normalized ratio.

    Measured: Up to Day 33 from screening for part one, up to Day 22 from screening for part two, and up to Day 16 from screening for part three.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start20 Oct 2021
  3. Primary completion1 Dec 2021
  4. Study completion1 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05045313
Sponsor's protocol ID
HA1118-CSP-012
Status last verified
Aug 2021
First submitted
5 Aug 2021
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Warfarin sodium tablets, Digoxin tablet and Probenecid tablets in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part one: Peak plasma concentration (Cmax) of S-warfarin and R-warfarin (time frame: Day 1 to Day 8, and Day 19 to Day 26). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05045313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.

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