- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04859439
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment
An Open-label, Single-dose, Phase I Clinical Study to Assess the Pharmacokinetics and Safety of DBPR108 Tablets in Subjects With Varying Degrees of Renal Impairment Compared to the Control Subjects With Normal Renal Function
Study Overview
Detailed Description
This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics, safety, and tolerability of a single dose of DBPR108 100 mg in subjects with mild, moderate, and severe renal impairment (RI), subjects with kidney failure and the control subjects with normal renal function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 3), and a follow-up call on Day 6.
Subjects will be enrolled in the following groups:
Estimated glomerular filtration rate (eGFR) will be calculated based on Modification of Diet in Renal Disease (MDRD) equation at screening.
(A) mild renal impairment (60 ≤ eGFR≤ 89 mL/min/1.73m2); (B) moderate renal impairment (30 ≤ eGFR≤ 59 mL/min/1.73m2); (C) severe renal impairment (15 ≤ eGFR≤ 29 mL/min/1.73m2); (D) kidney failure (<15 mL/min/1.73m2, not on hemodialysis); (E) control subjects with normal renal function will be matched with subjects with HI by weight, age, and sex (eGFR≥90 mL/min/1.73m2).
Approximately 8 subjects will be enrolled in each group.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Suzhou, China
- First Affiliated Hospital of Soochow University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All subjects:
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 years to 79 years (inclusive), male and female;
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m2));
- Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration;
Subjects with RI only:
- Subjects with medically stable RI corresponding to the Classifications of Renal Function based on eGFR: mild RI: 60 to 89 ml/min/1.73m2; moderate RI: 30 to 59 ml/min/1.73m2, severe RI:15-29 ml/min/1.73m2, kidney failure:<15 ml/min/1.73m2 (not on hemodialysis);
- 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 RI/ other comorbidities with no effect on the study drug absorption, distribution, metabolism, or excretion (last more than four weeks in good compliance);
- Based on physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests (serum potassium: 3.5-5.5 mmol/L);
Subjects with normal renal function only:
- Weight, age, and sex must be matched with subjects with HI;
- eGFR≥90 ml/min/1.73m2;
- 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 renal disease with no effect on the study drug absorption, distribution, metabolism, or excretion (last more than four weeks in good compliance).
Exclusion Criteria:
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, liver, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening;
- 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;
- Have acute hepatitis or a chronic liver disease; aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin > 2 × upper limit of normal;
- Have a positive result for hepatitis B surface antigen, hepatitis C virus antibody, 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;
- Currently receiving, or unable to refrain from expected concomitant cytochrome (CYP) 3A inhibitors and inducers;
- Not suitable for this study as judged by the investigator.
Study Plan
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 |
Intervention / Treatment |
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Experimental: Mild Renal Impairment
Subjects will receive a single dose of 100 mg DBPR108
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Drug: DBPR108, tablet, oral
Other Names:
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Experimental: Moderate Renal Impairment
Subjects will receive a single dose of 100 mg DBPR108
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Drug: DBPR108, tablet, oral
Other Names:
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Experimental: Severe Renal function
Subjects will receive a single dose of 100 mg DBPR108
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Drug: DBPR108, tablet, oral
Other Names:
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Experimental: Kidney failure
Subjects will receive a single dose of 100 mg DBPR108
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Drug: DBPR108, tablet, oral
Other Names:
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Experimental: Normal Renal function
Subjects will receive a single dose of 100 mg DBPR108
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Drug: DBPR108, tablet, oral
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pharmacokinetic parameters of DBPR108 in plasma
Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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Cmax
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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AUC0-t
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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AUC0-inf
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in urine
Time Frame: predose and 48 hours after dosing
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Ae
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predose and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in urine
Time Frame: predose and 48 hours after dosing
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fe
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predose and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in urine
Time Frame: predose and 48 hours after dosing
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CLR
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predose and 48 hours after dosing
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pharmacokinetic parameters of DBPR108 in plasma
Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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Tmax
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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t1/2
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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Vz/F
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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CL/F
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Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in urine
Time Frame: predose and 48 hours after dosing
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Ae(t1-t2)
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predose and 48 hours after dosing
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The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: Day 1 to Day 6
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The number of volunteers with adverse events as a measure of safety and tolerability
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Day 1 to Day 6
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HA1118-CSP-009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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