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

NCT05094934 | Terminated Phase 1

• 3 other identifiers: NN6435-4749U1111-1264-26932021-000462-16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434

  From last dose (Day 10) to post treatment follow-up (Day 65)

• tmax,0434,Day10: time from last dose administration to maximum plasma concentration of oral NNC0385-0434

  From last dose (Day 10) to post treatment follow-up (Day 65)

• t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434

  From last dose (Day 10) to post treatment follow-up (Day 65)

• CLR,0434,Day10; the renal clearance of NNC0385-0434 after last dose of oral NNC0385-0434

  From last dose (Day 10) to 48 hours post treatment (Day 12)

• 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

  From last dose (Day 10) to 24 hours post treatment (Day 11)

Study Arms (4)

Normal renal function

ACTIVE COMPARATOR

All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days

Drug: NNC0385-0434 A 100 mg

Mildly decreased renal function

EXPERIMENTAL

All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days

Drug: NNC0385-0434 A 100 mg

Moderately decreased renal function

EXPERIMENTAL

All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days

Drug: NNC0385-0434 A 100 mg

Severely decreased renal function

EXPERIMENTAL

All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days

Drug: NNC0385-0434 A 100 mg

Interventions

NNC0385-0434 A 100 mg DRUG

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.

Mildly decreased renal function; Moderately decreased renal function; Normal renal function; Severely decreased renal function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Normal renal function more than or equal to 90
• Mildly decreased renal function 60 - less than 90
• Moderately decreased renal function 30 - less than 60
• Severely decreased renal function less than 30 not requiring dialysis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 26, 2021
• Study Start: November 9, 2021
• Primary Completion: July 15, 2022
• Study Completion: August 24, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)