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

NCT ID: NCT05094934

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2022-08-24

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal renal function

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

Group Type: ACTIVE_COMPARATOR

NNC0385-0434 A 100 mg

Intervention Type: 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

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

Group Type: EXPERIMENTAL

NNC0385-0434 A 100 mg

Intervention Type: 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.

Moderately decreased renal function

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

Group Type: EXPERIMENTAL

NNC0385-0434 A 100 mg

Intervention Type: 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.

Severely decreased renal function

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

Group Type: EXPERIMENTAL

NNC0385-0434 A 100 mg

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

U1111-1264-2693

Identifier Type: OTHER

Identifier Source: secondary_id

2021-000462-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN6435-4749

Identifier Type: -

Identifier Source: org_study_id