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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05094934
• Other study ID #: NN6435-4749
• Secondary ID: U1111-1264-26932
• Status: Terminated
• Phase: Phase 1
• Start date: November 9, 2021
• Est. completion date: August 24, 2022

Study information

• Verified date: December 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: August 24, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• NNC0385-0434 A 100 mg
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.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measured in h*nmol/L	From last dose (Day 10) to 24 hours post treatment (Day 11)
Secondary	Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434	nmol/L	From last dose (Day 10) to post treatment follow-up (Day 65)
Secondary	tmax,0434,Day10: time from last dose administration to maximum plasma concentration of oral NNC0385-0434	h	From last dose (Day 10) to post treatment follow-up (Day 65)
Secondary	t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434	h	From last dose (Day 10) to post treatment follow-up (Day 65)
Secondary	CLR,0434,Day10; the renal clearance of NNC0385-0434 after last dose of oral NNC0385-0434	mL/h	From last dose (Day 10) to 48 hours post treatment (Day 12)
Secondary	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	h*ng/mL	From last dose (Day 10) to 24 hours post treatment (Day 11)
Secondary	Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434	ng/mL	From last dose (Day 10) to 24 hours post treatment (Day 11)
Secondary	Cmin,SNAC,Day10; the minimum plasma concentration of SNAC before last dose of oral NNC0385-0434	nmol/L	Pre-dose (Day 10)
Secondary	tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434	hours	From last dose (Day 10) to 24 hours post treatment (Day 11)
Secondary	CLR,SNAC,Day10; the renal clearance of SNAC after last dose of oral NNC0385-0434	mL/h	From last dose (Day 10) to 48 hours post treatment (Day 12)
Secondary	Number of treatment emergent adverse events (TEAEs)	Number of events	From first dose (Day 1) until completion of the post-treatment period at follow-up (Day 65)