Healthy VolunteersPhase 1NCT05003440
A Research Study Looking at How the Medicine NNC0385-0434 Works in the Body of Healthy Japanese Men
A Phase 1 study testing NNC0385-0434 in people with Healthy Volunteers and Atherosclerotic Cardiovascular Disease, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
The aim of this study is to look at how the study medicine works in the body and how it is removed from the body. We are testing the study medicine to make a medicine that can help people lower their cholesterol level. Participants will either get 1. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Atherosclerotic Cardiovascular Disease
- What is being tested?
- NNC0385-0434
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 19 Aug 2021to 19 Jan 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight greater than or equal to 54.0 kg.
- Body mass index (BMI) between 20.0 and 34.9 kg/m^2 (both inclusive).
Who cannot join
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0385-0434 in Healthy, Male Japanese Participants
The aim of this study is to look at how the study medicine works in the body and how it is removed from the body.
We are testing the study medicine to make a medicine that can help people lower their cholesterol level.
Read more
Participants will either get
- NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg.
- placebo (a dummy medicine which looks like the study medicine but without any medicine).
Which treatment participants get is decided by chance. NNC0385-0434 is a new medicine and has not been approved by the Health Authorities (Centre for Drug Evaluation).
Participants will get 1 tablet per day for 10 days. The tablet will be handed out by a study doctor or site staff at the clinic and the study will last between 62 and 98 days.
Participants will have 7 clinic visits. One of these visits will be a 13-day, 12-night stay (V2) and the rest will be 1-day visits (V1 and V3 to V7).
At all visits, except the information visit, participants will have blood drawn along with other clinical checks.
Participants will be asked about their health, medical history and habits including mental health.
- Being tested
- NNC0385-0434, Placebo
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0385-0434Drug
Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg
PlaceboDrug
Participants will get 1 tablet (oral use) of placebo per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| NNC0385-0434 15 mg | Experimental | 15 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days Receives: Drug: NNC0385-0434 |
| Placebo (NNC0385-0434 15 mg) | Placebo comparator | Oral placebo will be administered once-daily over 10 consecutive days Receives: Drug: Placebo |
| NNC0385-0434 40 mg | Experimental | 40 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days Receives: Drug: NNC0385-0434 |
| Placebo (NNC0385-0434 40 mg) | Placebo comparator | Oral placebo will be administered once-daily over 10 consecutive days Receives: Drug: Placebo |
| NNC0385-0434 100 mg | Experimental | 100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days Receives: Drug: NNC0385-0434 |
| Placebo (NNC0385-0434 100 mg) | Placebo comparator | Oral placebo will be administered once-daily over 10 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Count of events
Measured: From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65)
Secondary outcomes (8)
AUC0-24h,0434,Day10,; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434
h*nmol/L
Measured: From last dose (day 10) 0 to 24 hours post treatment (day 11)
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) 0 hours to post treatment follow-up (day 65)
tmax,0434,Day10; the time to maximum observed plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
hours
Measured: From last dose (day 10) 0 hours to post treatment follow-up (day 65)
t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434
hours
Measured: From last dose (day 10) 0 hours to post treatment follow-up (day 65)
AUC0-24h,SNAC,Day10,; the area under the SNAC plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434
h*nmol/L
Measured: From last dose (day 10) 0 to 24 hours post treatment (day 11)
Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434
nmol/L
Measured: From last dose (day 10) 0 to 24 hours post treatment (day 11)
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) 0 to 24 hours post treatment follow-up (day 11)
t½,SNAC,Day10; the terminal half-life of SNAC after last dose of oral NNC0385-0434
hours
Measured: From last dose (day 10) 0 to 24 hours post treatment follow-up (day 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start19 Aug 2021
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single group
- Model description
- The study consists of two parts. Part 1 consists of three sequential dose ascension cohorts each with 4 healthy Japanese participants, randomised 3:1. The purpose of Part 1 is to provide safety clearance for initiating Part 2 and the randomisation of Japanese participants into the phase 2 study NN6435-4697. Part 2 will randomise the remaining Japanese participants into three parallel dose groups. (3:1:3:1:3:1).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003440
- Sponsor's protocol ID
- NN6435-4748
- Other IDs
- U1111-1264-4546, jRCT2071210055
- Status last verified
- Jan 2024
- First submitted
- 10 Aug 2021
- Last updated
- 17 Jan 2024
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0385-0434 in Healthy, Male Japanese Participants
- ClinicalTrials.gov ID
- NCT05003440
- Acronym / sponsor ID
- NN6435-4748
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 12 Aug 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.
The aim of this study is to look at how the study medicine works in the body and how it is removed from the body.
We are testing the study medicine to make a medicine that can help people lower their cholesterol level.
Participants will either get
- NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg.
- placebo (a dummy medicine which looks like the study medicine but without any medicine).
Which treatment participants get is decided by chance. NNC0385-0434 is a new medicine and has not been approved by the Health Authorities (Centre for Drug Evaluation).
Participants will get 1 tablet per day for 10 days. The tablet will be handed out by a study doctor or site staff at the clinic and the study will last between 62 and 98 days.
Participants will have 7 clinic visits. One of these visits will be a 13-day, 12-night stay (V2) and the rest will be 1-day visits (V1 and V3 to V7).
At all visits, except the information visit, participants will have blood drawn along with other clinical checks.
Participants will be asked about their health, medical history and habits including mental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- The study consists of two parts. Part 1 consists of three sequential dose ascension cohorts each with 4 healthy Japanese participants, randomised 3:1. The purpose of Part 1 is to provide safety clearance for initiating Part 2 and the randomisation of Japanese participants into the phase 2 study NN6435-4697. Part 2 will randomise the remaining Japanese participants into three parallel dose groups. (3:1:3:1:3:1).
| Arm | Type | Receives |
|---|---|---|
| NNC0385-0434 15 mg | Experimental | Drug: NNC0385-043415 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
| Placebo (NNC0385-0434 15 mg) | Placebo comparator | Drug: PlaceboOral placebo will be administered once-daily over 10 consecutive days |
| NNC0385-0434 40 mg | Experimental | Drug: NNC0385-043440 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
| Placebo (NNC0385-0434 40 mg) | Placebo comparator | Drug: PlaceboOral placebo will be administered once-daily over 10 consecutive days |
| NNC0385-0434 100 mg | Experimental | Drug: NNC0385-0434100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
| Placebo (NNC0385-0434 100 mg) | Placebo comparator | Drug: PlaceboOral placebo will be administered once-daily over 10 consecutive days |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight greater than or equal to 54.0 kg.
- Body mass index (BMI) between 20.0 and 34.9 kg/m^2 (both inclusive).
Key exclusion criteria (2 listed)
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
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 |
|---|---|---|
| NNC0385-0434Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg | Drug | NNC0385-0434 100 mg, NNC0385-0434 15 mg, NNC0385-0434 40 mg |
| PlaceboParticipants will get 1 tablet (oral use) of placebo per day for 10 days | Drug | Placebo (NNC0385-0434 100 mg), Placebo (NNC0385-0434 15 mg), Placebo (NNC0385-0434 40 mg) |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65)
Count of events
8 secondary outcomes
AUC0-24h,0434,Day10,; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434
Time frame: From last dose (day 10) 0 to 24 hours post treatment (day 11)
Cmax,0434,Day10,; the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
Time frame: From last dose (day 10) 0 hours to post treatment follow-up (day 65)
tmax,0434,Day10; the time to maximum observed plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
Time frame: From last dose (day 10) 0 hours 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) 0 hours to post treatment follow-up (day 65)
AUC0-24h,SNAC,Day10,; the area under the SNAC plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434
Time frame: From last dose (day 10) 0 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) 0 to 24 hours post treatment (day 11)
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) 0 to 24 hours post treatment follow-up (day 11)
t½,SNAC,Day10; the terminal half-life of SNAC after last dose of oral NNC0385-0434
Time frame: From last dose (day 10) 0 to 24 hours post treatment follow-up (day 11)
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 17 Jan 2024.
- 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. 1452) 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 Healthy Volunteers and Atherosclerotic Cardiovascular Disease, run by Novo Nordisk A/S at 1 site in Japan.
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 2 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: finished, as of the sponsor's last update on 17 Jan 2024. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
Number of treatment emergent adverse events (TEAEs) (time frame: From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65)). 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 17 Jan 2024.