Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD RiskPhase 1NCT05091073
A Research Study Looking at the Effect of Food Intake on How the Medicine NN0385-0434 Behaves in the Body of Healthy Participants
A Phase 1 study testing NNC0385-0434 in people with Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk and Elevated Cholesterol, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
In this study participants will receive NNC0385-0434. NNC0385-0434 is being developed for the treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of cholesterol in the blood. The dose to be tested in this study is 40 mg NNC0385-0434. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk, Elevated Cholesterol, Healthy Volunteers
- What is being tested?
- NNC0385-0434
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- 9 Dec 2021to 31 May 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male.
- Aged 18 to 55 (both inclusive).
- Considered to be generally healthy based on medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Body weight minimum 54 kg.
- Body mass index (BMI) between 20.0 and 34.9 kg/m^2 (both inclusive).
Who cannot join
- Any disorder, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
- Meal habits and diet requirements which are contradictory to the meals provided or unwillingness to eat the food provided in the study.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Food on the Pharmacokinetics of Oral NNC0385-0434 in Healthy Participants
In this study participants will receive NNC0385-0434. NNC0385-0434 is being developed for the treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of cholesterol in the blood. The dose to be tested in this study is 40 mg NNC0385-0434.
NNC0385-0434 is a new potential medicine that is currently being tested for intake as a tablet. It is not yet approved and cannot be prescribed yet. Besides 40 mg of NNC0385-0434, each tablet also contains 500 mg of the absorption enhancing agent SNAC, which helps to move NNC0385-0434 from the stomach into the blood.
Read more
The aim of this study is to investigate the effect of food intake on the amount of NNC0385-0434 in the blood after multiple tablet intake. For this purpose, NNC0385-0434 is given either after a high-fat breakfast or on an empty stomach. After dosing, participants must either fast for another 4 hours or receive a meal 30 minutes after dosing, depending on the group participants are assigned to. After taking the NNC0385-0434 tablets, the amount of NNC0385-0434 (and of SNAC) in the blood will be measured. The effect of food intake on the uptake of NNC0385-0434 into the body will be investigated so that correct and safe intake recommendations and medicine labels can be given.
The study can last for up to approximately 14 weeks for each participant, with a total of 7 clinic visits. This includes a screening period (up to 4 weeks) and one in-house treatment period (together a total of 13 consecutive days). It also includes a follow-up period with 5 ambulatory visits at the clinic (for approximately 7 weeks [total of 50 days] after the last dosing). participants will have blood tests at every clinic visit. Participants must be healthy and have a body mass index (BMI) between 20.0 and 34.9 kg/m2 (both inclusive). Only men can participate in this clinical study.
- Conditions
- Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk, Elevated Cholesterol, Healthy Volunteers
- Being tested
- NNC0385-0434
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0385-0434Drug
All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Fed group | Experimental | Fed dosing conditions Receives: Drug: NNC0385-0434 |
| Fasting group | Experimental | Fasting dosing conditions Receives: Drug: NNC0385-0434 |
| Reference group | Active comparator | Reference dosing conditions Receives: Drug: NNC0385-0434 |
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 0 to 24 h after last dose of oral NNC0385-0434
h*nmol/L
Measured: From last dose (Day 10) to 24 hours post treatment (Day 11)
Secondary outcomes (3)
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: the time to maximum observed plasma concentration of NNC0385-0434 after last dose of NNC0385-0434
hours
Measured: From last dose (Day 10) to post treatment follow-up (Day 65)
t1/2,0434,Day10: the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434
hours
Measured: From last dose (Day 10) to post treatment 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 posted25 Oct 2021
- Study start9 Dec 2021
- Primary completion7 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD RiskStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 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
- NCT05091073
- Sponsor's protocol ID
- NN6435-4826
- Other IDs
- U1111-1264-4693, 2021-000430-34
- Status last verified
- Dec 2023
- First submitted
- 22 Oct 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
- Effect of Food on the Pharmacokinetics of Oral NNC0385-0434 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05091073
- Acronym / sponsor ID
- NN6435-4826
- Conditions
- Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk, Elevated Cholesterol, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 25 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.
In this study participants will receive NNC0385-0434. NNC0385-0434 is being developed for the treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of cholesterol in the blood. The dose to be tested in this study is 40 mg NNC0385-0434.
NNC0385-0434 is a new potential medicine that is currently being tested for intake as a tablet. It is not yet approved and cannot be prescribed yet. Besides 40 mg of NNC0385-0434, each tablet also contains 500 mg of the absorption enhancing agent SNAC, which helps to move NNC0385-0434 from the stomach into the blood.
The aim of this study is to investigate the effect of food intake on the amount of NNC0385-0434 in the blood after multiple tablet intake. For this purpose, NNC0385-0434 is given either after a high-fat breakfast or on an empty stomach. After dosing, participants must either fast for another 4 hours or receive a meal 30 minutes after dosing, depending on the group participants are assigned to. After taking the NNC0385-0434 tablets, the amount of NNC0385-0434 (and of SNAC) in the blood will be measured. The effect of food intake on the uptake of NNC0385-0434 into the body will be investigated so that correct and safe intake recommendations and medicine labels can be given.
The study can last for up to approximately 14 weeks for each participant, with a total of 7 clinic visits. This includes a screening period (up to 4 weeks) and one in-house treatment period (together a total of 13 consecutive days). It also includes a follow-up period with 5 ambulatory visits at the clinic (for approximately 7 weeks [total of 50 days] after the last dosing). participants will have blood tests at every clinic visit. Participants must be healthy and have a body mass index (BMI) between 20.0 and 34.9 kg/m2 (both inclusive). Only men can participate in this clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fed group | Experimental | Drug: NNC0385-0434Fed dosing conditions |
| Fasting group | Experimental | Drug: NNC0385-0434Fasting dosing conditions |
| Reference group | Active comparator | Drug: NNC0385-0434Reference dosing conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male.
- Aged 18 to 55 (both inclusive).
- Considered to be generally healthy based on medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Body weight minimum 54 kg.
- Body mass index (BMI) between 20.0 and 34.9 kg/m^2 (both inclusive).
Key exclusion criteria (3 listed)
- Any disorder, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
- Meal habits and diet requirements which are contradictory to the meals provided or unwillingness to eat the food provided in the study.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
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 |
|---|---|---|
| NNC0385-0434All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days | Drug | Fasting group, Fed group, Reference group |
Primary outcome
AUC0-24h,0434,Day10: the area under the NNC0385-0434 plasma concentration-time curve from 0 to 24 h after last dose of oral NNC0385-0434
Time frame: From last dose (Day 10) to 24 hours post treatment (Day 11)
h*nmol/L
3 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: the time to maximum observed plasma concentration of NNC0385-0434 after last dose of NNC0385-0434
Time frame: From last dose (Day 10) to post treatment follow-up (Day 65)
t1/2,0434,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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
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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 in people with Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk and Elevated Cholesterol, 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 5 inclusion and 3 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 0 to 24 h 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.