Clinical trial NCT05094934: A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is Tolerated in Participants With Impaired Kidney Function Compared to Participants With Normal Kidney Function
Official title: Investigation of Pharmacokinetics, Safety and Tolerability of Oral NNC0385-0434 in Participants With Various Degrees of Impaired Renal Function and in Participants With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Novo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level.

The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with impaired kidney function.

All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day.

The study will last for about 9-14 weeks.

Participants will have 15 visits to the study centre, including 2 in-house stays of 3 days and 2 nights and 13 ambulatory visits.

Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood draws, urine will be collected and electrocardiograms (ECGs) will be recorded.

Participants cannot take part in the study if they have gastrointestinal disorders or unusual meal habits and special dietary requirements.

Women can only take part in the study if they cannot get pregnant.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 20.0 and 34.9 kg/m\^2 (both inclusive).
* Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to KDIGO 2012:

Group description eGFR (mL/min)

1. Normal renal function more than or equal to 90
2. Mildly decreased renal function 60 - less than 90
3. Moderately decreased renal function 30 - less than 60
4. Severely decreased renal function less than 30 not requiring dialysis

Exclusion Criteria:

* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the study doctor.
* Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the study.

Primary outcomes:
measure: AUC0-24h,0434,Day10: the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 hours after last dose of oral NNC0385-0434
timeFrame: From last dose (Day 10) to 24 hours post treatment (Day 11)
Secondary outcomes:
measure: Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
timeFrame: From last dose (Day 10) to post treatment follow-up (Day 65)
measure: tmax,0434,Day10: time from last dose administration to maximum plasma concentration of oral NNC0385-0434
timeFrame: From last dose (Day 10) to post treatment follow-up (Day 65)
measure: t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434
timeFrame: From last dose (Day 10) to post treatment follow-up (Day 65)
measure: CLR,0434,Day10; the renal clearance of NNC0385-0434 after last dose of oral NNC0385-0434
timeFrame: From last dose (Day 10) to 48 hours post treatment (Day 12)
measure: AUC0-24h,SNAC,Day10: the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after last dose of oral NNC0385-0434
timeFrame: From last dose (Day 10) to 24 hours post treatment (Day 11)
measure: Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434
timeFrame: From last dose (Day 10) to 24 hours post treatment (Day 11)
measure: Cmin,SNAC,Day10; the minimum plasma concentration of SNAC before last dose of oral NNC0385-0434
timeFrame: Pre-dose (Day 10)
measure: tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434
timeFrame: From last dose (Day 10) to 24 hours post treatment (Day 11)
measure: CLR,SNAC,Day10; the renal clearance of SNAC after last dose of oral NNC0385-0434
timeFrame: From last dose (Day 10) to 48 hours post treatment (Day 12)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From first dose (Day 1) until completion of the post-treatment period at follow-up (Day 65)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: