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

December 22, 2023 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Normal renal function
All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days
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.
Experimental: Mildly decreased renal function
All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days
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.
Experimental: Moderately decreased renal function
All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days
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.
Experimental: Severely decreased renal function
All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: From last dose (Day 10) to 24 hours post treatment (Day 11)
Measured in h*nmol/L
From last dose (Day 10) to 24 hours post treatment (Day 11)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
Time Frame: From last dose (Day 10) to post treatment follow-up (Day 65)
nmol/L
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
Time Frame: From last dose (Day 10) to post treatment follow-up (Day 65)
h
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
Time Frame: From last dose (Day 10) to post treatment follow-up (Day 65)
h
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
Time Frame: From last dose (Day 10) to 48 hours post treatment (Day 12)
mL/h
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
Time Frame: From last dose (Day 10) to 24 hours post treatment (Day 11)
h*ng/mL
From last dose (Day 10) to 24 hours post treatment (Day 11)
Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434
Time Frame: From last dose (Day 10) to 24 hours post treatment (Day 11)
ng/mL
From last dose (Day 10) to 24 hours post treatment (Day 11)
Cmin,SNAC,Day10; the minimum plasma concentration of SNAC before last dose of oral NNC0385-0434
Time Frame: Pre-dose (Day 10)
nmol/L
Pre-dose (Day 10)
tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434
Time Frame: From last dose (Day 10) to 24 hours post treatment (Day 11)
hours
From last dose (Day 10) to 24 hours post treatment (Day 11)
CLR,SNAC,Day10; the renal clearance of SNAC after last dose of oral NNC0385-0434
Time Frame: From last dose (Day 10) to 48 hours post treatment (Day 12)
mL/h
From last dose (Day 10) to 48 hours post treatment (Day 12)
Number of treatment emergent adverse events (TEAEs)
Time Frame: From first dose (Day 1) until completion of the post-treatment period at follow-up (Day 65)
Number of events
From first dose (Day 1) until completion of the post-treatment period at follow-up (Day 65)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN6435-4749
  • U1111-1264-2693 (Other Identifier: World Health Organization (WHO))
  • 2021-000462-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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