Phase
Condition
Diabetes Mellitus, Type 2
Treatment
NNC0519-0130
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female of non-childbearing potential, aged 18-75 years (both inclusive) atthe time of signing the informed consent.
Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m^2) (bothinclusive) at screening.
Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimatedGFR (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI)Creatinine Equation (2021) adjusted for estimated individual body surface area (BSA)for any of the renal function groups:
For participants with normal renal function: eGFR of greater than or equal to 90millilitres per minute (mL/min)
Stage 2: For participants with mild renal impairment: eGFR of 60-89 mL/min
Stage 3: For participants with moderate renal impairment: eGFR of 30-59 mL/min
Stage 4: For participants with severe renal impairment: eGFR of 15-29 mL/min notrequiring dialysis
Stage 5: For participants with kidney failure: eGFR of less than 15 mL/min andrequiring dialysis treatment
Exclusion
Exclusion Criteria:
Any disorder which in the investigator's opinion might jeopardise participant'ssafety or compliance with the protocol.
Presence or history of any clinically relevant respiratory, metabolic, renal,hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (exceptconditions associated with renal impairment or kidney failure) as judged by theinvestigator.
Use of drugs known to affect creatinine clearance including cephalosporin andaminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim,cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater,before planned dosing of the investigational medicinal product (IMP).
Study Design
Connect with a study center
Charité Research Organisation GmbH
Berlin, 10117
GermanySite Not Available
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