Chronic Kidney DiseasePhase 1NCT05094934
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
A Phase 1 study testing NNC0385-0434 A 100 mg in people with Chronic Kidney Disease, run by Novo Nordisk A/S at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- NNC0385-0434 A 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 9 Nov 2021to 24 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- NNC0385-0434 A 100 mg
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0385-0434 A 100 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Active comparator | All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days Receives: 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 Receives: 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 Receives: 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 Receives: Drug: NNC0385-0434 A 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
nmol/L
Measured: 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
h
Measured: 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
h
Measured: 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
mL/h
Measured: 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
h*ng/mL
Measured: 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
ng/mL
Measured: 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
nmol/L
Measured: Pre-dose (Day 10)
tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434
hours
Measured: 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
mL/h
Measured: From last dose (Day 10) to 48 hours post treatment (Day 12)
Number of treatment emergent adverse events (TEAEs)
Number of events
Measured: From first dose (Day 1) until completion of the post-treatment period at follow-up (Day 65)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start9 Nov 2021
- Primary completion15 Jul 2022
- Study completion24 Aug 2022
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094934
- Sponsor's protocol ID
- NN6435-4749
- Other IDs
- U1111-1264-2693, 2021-000462-16
- Status last verified
- Dec 2023
- First submitted
- 27 Sep 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05094934
- Acronym / sponsor ID
- NN6435-4749
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Active comparator | Drug: NNC0385-0434 A 100 mgAll participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days |
| Mildly decreased renal function | Experimental | Drug: NNC0385-0434 A 100 mgAll participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days |
| Moderately decreased renal function | Experimental | Drug: NNC0385-0434 A 100 mgAll participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days |
| Severely decreased renal function | Experimental | Drug: NNC0385-0434 A 100 mgAll participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0385-0434 A 100 mgAll 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. | Drug | Mildly decreased renal function, Moderately decreased renal function, Normal renal function, Severely decreased renal function |
Primary outcome
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
10 secondary outcomes
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)
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)
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)
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)
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)
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)
Cmin,SNAC,Day10; the minimum plasma concentration of SNAC before last dose of oral NNC0385-0434
Time frame: 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)
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)
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)
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0385-0434 A 100 mg in people with Chronic Kidney Disease, run by Novo Nordisk A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From last dose (Day 10) to 24 hours post treatment (Day 11)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.