NCT04221399
Unknown
Phase 1
A Single- and Multiple-Dose Clinical Study to Evaluate Pharmacokinetics and Pharmacodynamics of DWP16001 Following Oral Dose in Type 2 Diabetes Patients With Renal Impairment
Daewoong Pharmaceutical Co. LTD.0 sites35 target enrollmentStarted: January 2020Last updated:
Overview
- Phase
- Phase 1
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 35
- Primary Endpoint
- Concentration-time curve [AUC]
Overview
Brief Summary
The purpose of the study is to evaluate the effect of kidney function on pharmacokinetics and pharmacodynamics of DWP16001 following single and multiple oral doses in type 2 diabetes patients with normal kidney function and renal impairment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged ≥ 19 years at the time of screening test
- •Body weight of ≥ 50.0 kg to ≤ 90.0 with a body mass index (BMI) of ≥ 20.0 to ≤ 45.0
- •Have been diagnosed with type 2 diabetes
Exclusion Criteria
- •Have clinically uncontrolled or unstable hepatic, neurological, immune system, respiratory, hemato-oncology, cardiovascular, or psychiatric disorder (subject with chronic disease such as hypertension, diabetes, and hyperlipidemia that is well controlled or stable is eligible to participate in the study based on investigator's judgement)
- •History of gastrointestinal diseases, dialysis, kidney transplantation, HIV, hepatitis B or C, acute or chronic infection, recent diabetic ketoacidosis, or gastrointestinal surgery that may affect the absorption of the study drug
- •Received SGLT2 inhibitors or drugs of thiazolidinedione class within 6 weeks of scheduled IP administration day
- •Clinical laboratory test values are outside the accepted normal range at screening
- •AST (SGOT), ALT (SGPT) \> 2 x the upper limit of normal
- •Repeatedly confirmed QTc interval \> 450 ms
- •Sitting systolic blood pressure \< 80 mmHg or \> 180 mmHg or sitting diastolic blood pressure \< 60 mmHg or \> 110 mmHg after resting for more than 3 minutes
- •Other exclusive inclusion criteria, as defined in the protocol
Arms & Interventions
DWP16001 Single dose
Experimental
Single dose
Intervention: DWP16001 (Drug)
DWP16001 Multiple dose
Experimental
Up to 7 days
Intervention: DWP16001 (Drug)
Outcomes
Primary Outcomes
Concentration-time curve [AUC]
Time Frame: on Days 1 to 4 at selected time points
Concentration of serum glucose
Time Frame: on Days 1 to 4 at selected time points
Maximum Plasma Concentration [Cmax]
Time Frame: on Days 1 to 4 at selected time points
Urine glucose (g/day)
Time Frame: on Days -1 to 4
Cummulative by time
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Phase 1
A Research Study of How a New Medicine NNC0148-0287 C (Insulin 287) Works in the Body of People With Kidney ProblemsDiabetes Mellitus, Type 2NCT03723785Novo Nordisk A/S58
Completed
Phase 1
Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female SubjectsRenal FunctionNCT02634437Allergan19
Completed
Phase 1
PK Study of ACHN-490 Injection in Renally Impaired SubjectsRenal InsufficiencyNCT01462136Achaogen, Inc.24
Completed
Phase 1
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal DysfunctionChronic Hepatitis B Virus InfectionChronic Hepatitis C Virus InfectionNCT01708889Bristol-Myers Squibb43
Completed
Phase 1
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal FunctionRenal ImpairmentNCT02508506Alkermes, Inc.22