A Research Study Looking Into How a Single Dose of the Medicine NNC0537-1482 Moves Through the Body of Participants With Normal or Reduced Kidney Function

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNovo Nordisk A/S

About this trial

The purpose of the study to find out how the study medicine NNC0537-1482 moves through the body in people living with reduced kidney function compared to people with normal kidney function. All participants will get a single dose of the new medicine. The data for how much medicine is in the blood over time and compare levels between people with reduced and normal kidney function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body Mass Index (BMI) between 18.5 and 39.9 Kilogram per meter square (kg/m²) (both inclusive) at screening.

All participants in the renal impairment groups should have had chronic kidney disease for at least 3 months prior to screening.

Disqualifiers

Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).

Use of medicinal products known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing with the investigational medicinal product (IMP).

Ongoing treatment with nitrates or nitric oxide (NO) donors (for any route; including isosorbide dinitrate, isosorbide 5 mononitrate, pentaerythritol tetranitrate, nicorandil, nitroglycerin , molsidomine), neprilysin inhibitors (including angiotensin receptor/neprilysin inhibitors), phosphodiesterase (PDE) inhibitors (including PDE3, PDE4, PDE5 inhibitors), or soluble guanylate cyclase (sGC) stimulators.

Trial design

Design model

Single group

Treatments tested in this trial

  • NNC0537-1482

    Drug

    NNC0537-1482 will be administered subcutaneously.

  • Placebo (for dilution only)

    Other intervention

    A placebo was used for dilution of the investigational medicinal product.

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: NNC0537-1482Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with normal function and mild, moderate and severe impairment

Measured as hour per nanomoles per liter (h\*nmol/L).

Time frame
From pre-dose (Day 1) until Day 36

Secondary outcomes

1

Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with normal function and mild, moderate and severe impairment

Measured as nanomoles per liter (nmol/L).

Time frame
From pre-dose (Day 1) until Day 36
2

Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with normal function and mild, moderate and severe impairment

Measured as hours.

Time frame
From pre-dose (Day 1) until Day 36
3

Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with end-stage renal disease (ESRD)

Measured as h\*nmol/L.

Time frame
From pre-dose (Day 1) until Day 36
4

Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD)

Measured as nmol/L.

Time frame
From pre-dose (Day 1) until Day 36

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: